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Evusheld combination approved for prevention & treatment of COVID-19

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Evusheld combination approved for prevention & treatment of COVID-19

August 30, 2022: “AstraZeneca’s Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection.

The decision marks the first global marketing approval for Evusheld as a treatment for COVID-19.

In prevention, Japan’s Ministry of Health, Labour and Welfare (MHLW) granted Evusheld Special Approval for Emergency for adults and adolescents (12 years of age and older weighing at least 40kg). 

Evusheld is approved for use in those whom SARS-CoV-2 vaccination is not recommended and who may have an inadequate response to a COVID-19 vaccine due to immunodeficiencies.

Recipients of Evusheld for prevention should not be currently infected with or have had recent known exposure to a person infected with SARS-CoV-2.

In treatment, Evusheld is approved for adults and adolescents (12 years of age and older weighing at least 40kg) with risk factors for severe SARS-CoV-2 infection who do not require supplemental oxygen.

Kazuhiro Tateda, M.D. Ph.D., Professor, Department of Microbiology and Infectious Disease, Toho University, Tokyo, Japan, said: “COVID-19 continues to have a significant impact on our daily lives in Japan.

Many people, including older adults, patients with comorbidities, and immunocompromised patients, remain at risk for poor outcomes from severe COVID-19. 

Evusheld will be a much-needed new option, offering long-term protection for those who do not achieve an adequate immune response after vaccination and helping prevent severe disease and death in those who do become infected.”

Itaru Matsumura, M.D., Ph.D. Professor & Chairman, Department of Hematology & Rheumatology, Kindai University Faculty of Medicine, Otsuka, Japan, said: “Despite the progress of vaccinations and stringent safety precautions, there are very large number of new infections in Japan.

The approval of Evusheld is expected to provide a non-vaccine prophylactic option for those who cannot expect a full immune response from COVID-19 vaccination, such as patients with blood cancers.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “The approvals of Evusheld in Japan represent an important milestone in our ongoing efforts to help combat COVID-19 on all fronts. 

Evusheld is now the only long-acting antibody combination authorised for both COVID-19 prevention and treatment, allowing us to help protect even more vulnerable patients such as the immunocompromised from this devastating disease.”

The Japanese government has agreed to purchase 300,000 units of Evusheld (150mg each of tixagevimab and cilgavimab), and AstraZeneca is working with the government and partners to make first doses available as soon as possible.

The approvals were based on efficacy and safety data from the Evusheld clinical development programme, including the PROVENT Phase III pre-exposure prophylaxis trial, the TACKLE Phase III outpatient treatment trial, and Phase I trials, including in Japan.

In PROVENT, a 300mg intramuscular (IM) dose of Evusheld significantly reduced the risk of developing symptomatic COVID-19 by 77% (95% confidence interval (CI): 46, 90; p<0.001) COVID-19 compared to placebo at the primary analysis.

An 83% (95% CI: 66, 91) relative risk reduction was shown at a six-month median follow-up analysis, with protection from the virus lasting six months.

In TACKLE, a 600mg IM dose of Evusheld significantly reduced the relative risk of progressing to severe COVID-19 or death (from any cause) by 50% (95% confidence interval [CI] 15, 71; p=0.010) through day 29 compared to placebo in non-hospitalised patients with mild-to-moderate COVID-19 who were symptomatic for seven days or less, the trial’s primary endpoint.

In pre-specified analyses of participants who received treatment within three days of symptom onset, Evusheld reduced the risk of developing severe COVID-19 or death (from any cause) by 88% compared to placebo (95% CI 9, 98), and the risk reduction was 67% (95% CI 31, 84) when participants received Evusheld within five days of symptom onset.2  

Evusheld was generally well-tolerated in the trials.

The recommended dose for prevention of symptomatic disease caused by SARS-CoV-2 infection in Japan is 150mg of tixagevimab and 150mg of cilgavimab, administered as separate sequential IM injections.

Depending on the prevalence of SARS-CoV-2 variants, 300mg of tixagevimab and 300mg of cilgavimab may be administered for prevention.

The recommended dose for treatment of COVID-19 is 300mg of tixagevimab and 300mg of cilgavimab, administered as separate sequential IM injections.

Evusheld has been shown to retain in vitro neutralisation activity against the main Omicron variants currently circulating globally, including BA.5 and BA.2.

Evusheld is also authorised for use for pre-exposure prophylaxis (prevention) of COVID-19 in the US (emergency use), EU and many other countries.

Regulatory submissions are progressing for both prevention and treatment indications around the world.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/evusheld-approved-for-covid-19-in-japan.html

Pfizer and BioNTech Announce Updated COVID-19 Vaccine Data Supporting Efficacy in Children

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Pfizer and BioNTech Announce Updated COVID-19 Vaccine Data Supporting Efficacy in Children

August 23, 2022: “Pfizer Inc. and BioNTech SE announced updated efficacy results from a Phase 2/3 trial evaluating a three 3-µg dose series of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age, reinforcing previously reported interim vaccine efficacy data collected in March and April 2022.

Emergency Use Authorization (EUA) of this vaccine was granted by the U.S. Food and Drug Administration (FDA) for this age group on June 17 and an application for conditional Marketing Authorization in this age group is under review by the European Medicines Agency (EMA).This press release features multimedia.

View the full release here: https://www.businesswire.com/news/home/20220823005341/en/

Participants in the study received either the Pfizer-BioNTech COVID-19 Vaccine (3-μg) as a three-dose series or placebo (2:1 randomization). Vaccine efficacy, a secondary endpoint in the trial, was 73.2% (2-sided 95% CI: 43.8%, 87.6%) among children 6 months through 4 years of age without evidence of prior COVID-19 infection.

This analysis was based on 13 cases in the Pfizer-BioNTech COVID-19 Vaccine group (n=794) and 21 cases in the placebo group (n=351), diagnosed from March to June 2022. The study protocol specified that this formal efficacy analysis should be performed when at least 21 total symptomatic COVID-19 cases were identified, each at least seven days after the third dose.

Consistent with the time period when the cases occurred, sequencing of viral RNA from illness visit nasal swabs indicated that observed cases were primarily caused by Omicron BA.2.

Omicron BA.4 and BA.5 strains were emerging during the period of the study, with only a few cases accrued and efficacy results against these strains were inconclusive.

Consistent with our approach in adults, we are working with the FDA to prepare an EUA application for an Omicron BA.4/BA.5-adapted bivalent vaccine in children 6 months through 11 years of age.

“Building on the strong safety and immunogenicity data that led to FDA authorization of our COVID-19 vaccine for children 6 months through 4 years, we are pleased to share confirmatory evidence that a full course of vaccination helps protect against symptomatic disease, particularly during a time when the Omicron BA.2 strain was predominant,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer.

“While these results confirm that three 3-µg doses of our COVID-19 vaccine provide young children with a high level of protection at a time when the Omicron BA.2 strain was highly prevalent with a favorable safety profile, we are also developing an Omicron BA.4/BA.5-adapted bivalent vaccine in this age group to address these sublineages,” said Prof. Ugur Sahin, M.D., CEO and Co-Founder of BioNTech.

Among children ages 6 through 23 months, the vaccine was 75.8% (2-sided 95% CI: 9.7%, 94.7%) effective at preventing COVID-19, based on 4 cases in the vaccine group (n=296) and 8 cases in the placebo group (n=147), after a median of 1.9 months (range: 0.0, 4.9) follow-up after the third dose.

For children ages 2 through 4 years of age, the vaccine was 71.8% (2-sided 95% CI: 28.6%, 89.4%) effective at preventing COVID-19, based on 9 cases in the vaccine group (n=498) and 13 cases in the placebo group (n=204), after a median of 2.4 months (range: 0.0, 4.9) follow-up after the third dose.

Three 3-µg doses of the Pfizer-BioNTech COVID-19 Vaccine continue to be well-tolerated in this age group.

The majority of adverse events observed in this age group have been mild or moderate, with a safety profile similar to placebo.

On July 8, Pfizer and BioNTech submitted safety and immunogenicity data to the European Medicines Agency (EMA) requesting an update to the Conditional Marketing Authorization (CMA) in the European Union (EU) to include children ages 6 months through 4 years.

The companies plan to submit the updated efficacy data to the FDA, EMA and other regulatory agencies around the world in the coming weeks.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 (COMIRNATY®) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

About the Phase 1/2/3 Trial in Children

The Phase 1/2/3 trial has enrolled more than 10,000 children ages 6 months to under 12 years of age in the United States, Finland, Poland, Brazil and Spain from more than 90 clinical trial sites.

The trial evaluated the safety, tolerability, and immunogenicity of three doses of the Pfizer-BioNTech COVID-19 Vaccine in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years.

Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10 µg each while children under age 5 received a lower 3 µg dose for each injection in the Phase 2/3 study.

The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.

U.S. Indication & Authorized Use

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older. Pfizer-BioNTech COVID-19 Vaccine is FDA authorized to provide:

Primary Series

  • A 3-dose primary series to individuals 6 months through 4 years of age
  • a 2-dose primary series to individuals 5 years through 11 years of age
  • a 2-dose primary series to individuals 12 years of age and older
  • a third primary series dose to individuals 5 years of age and older with certain kinds of immunocompromise

Booster Series

  • a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine
  • a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • a first booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
  • a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
  • a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine

COMIRNATY®INDICATION

COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

  • COMIRNATY® is administered as a 2-dose primary series

HOW IS COMIRNATY ® GIVEN?

COMIRNATY® is administered as an injection into the muscle as a 2-dose primary series, 3 weeks apart.

COMIRNATY® AUTHORIZED USES

COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA authorized under Emergency Use Authorization (EUA) to provide:

Primary Series

  • a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise

Booster Dose

  • a first booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
  • a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
  • a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
  • a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine

Emergency Use Authorization

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID 19) in individuals 6 months of age and older.

The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

INTERCHANGEABILITY

FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine FDA authorized for Emergency Use Authorization (EUA) for individuals 12 years of age and older can be used interchangeably by a vaccination provider when prepared according to their respective instructions for use.

The formulation of the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age, 5 through 11 years of age, and 12 years of age and older are different and should therefore not be used interchangeably.

IMPORTANT SAFETY INFORMATION

Tell your vaccination provider about all of the vaccine recipient’s medical conditions, including if the vaccine recipient:

  • has any allergies
  • has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • has a fever
  • has a bleeding disorder or is on a blood thinner
  • is immunocompromised or are on a medicine that affects the immune system
  • is pregnant, plan to become pregnant, or are breastfeeding
  • has received another COVID-19 vaccine
  • has ever fainted in association with an injection
  • Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) may not protect all vaccine recipients
  • The vaccine recipient should not receive Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) if the vaccine recipient has had a severe allergic reaction to any of its ingredients or had a severe allergic reaction to a previous dose of Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
  • There is a remote chance that Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) could cause a severe allergic reaction.
    A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine.
    For this reason, your vaccination provider may ask you to stay at the place where the vaccine was administered for monitoring after vaccination.
    If the vaccine recipient experiences a severe allergic reaction, call 9-1-1 or go to the nearest hospital
  • Seek medical attention right away if the vaccine recipient has any of the following symptoms: difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
  • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males.
    In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low

Seek medical attention right away if the vaccine recipient has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a vaccine dose:

  • Chest pain
  • Shortness of breath
  • Feelings of having a fast-beating, fluttering, or pounding heart
  • Fainting
  • Unusual and persistent irritability
  • Unusual and persistent poor feeding
  • Unusual and persistent fatigue or lack of energy
  • Persistent vomiting
  • Persistent pain in the abdomen
  • Unusual and persistent cool, pale skin
  • Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA). Sometimes people who faint can fall and hurt themselves.
    For this reason, your vaccination provider may ask the vaccine recipient to sit or lie down for 15 minutes after receiving the vaccine
  • Some people with weakened immune systems may have reduced immune responses to Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • Additional side effects include rash, itching, hives, swelling of the face, injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell, swollen lymph nodes (lymphadenopathy), decreased appetite, diarrhea, vomiting, arm pain, and fainting in association with injection of the vaccine and irritability

These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-updated-covid-19-vaccine-data

BrainVectis receives clearance to conduct clinical trial in France for early-stage Huntington’s Disease

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BrainVectis receives clearance to conduct clinical trial in France for early-stage Huntington’s Disease

August 23, 2022: “Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, has received clearance to conduct a Phase I/II trial for its novel Huntington’s Disease (HD) gene therapy, BV-101, in France through its subsidiary BrainVectis.

This authorization, provided by the National Agency for Safety of Medicines and Health Products (ANSM), the country’s governing drug authority, along with the approval of the trial protocol by the Ethics Committee in charge, enables the company to begin recruiting participants.

BV-101 is a novel, exclusively designed adeno-associated virus (AAV) gene therapy vector that simultaneously addresses the metabolic dysfunction of diseased neurons as well as contributes to the clearance of the mutant huntingtin protein.

BV-101 is administered through MRI-guided neurosurgical techniques directed to target tissues in the basal structures of the brain.

In preclinical studies in mice, BV-101 demonstrated the ability to repair the essential cholesterol pathway, provide neuroprotection, and restore physical performance by delivering CYP46A1, a crucial enzyme in the brain which is reduced in people with Huntington’s Disease.

BV-101 was granted orphan drug designation in the European Union in 2019 by the European Medicines Agency.

“Unlike other attempts to treat Huntington’s Disease, BV-101 aims to restore cholesterol metabolism, reduce mutant huntingtin and to improve neuronal function.

Importantly, BV-101 does not affect the levels of normal huntingtin protein in cells,” said Nathalie Cartier-Lacave, MD, founder of BrainVectis and now Vice President, Sector Lead Neurobiology, at AskBio.

“If this proves successful, we have the potential to change the course of a devastating disease that causes severe functional and cognitive decline.”

Currently there are no approved disease modifying therapies for HD, a rare inherited neurodegenerative disease that, based on information from the Committee for Orphan Medicinal Products (COMP), affects approximately 62,000 people in the European Union.

The disease is caused by anomalous repeating mutations in the huntingtin gene leading to abnormal protein aggregates in nerve cells.

This results in a range of progressive symptoms, leading to complete physical and mental deterioration, with symptoms usually beginning in adults ages 30 to 50, but which can also occur at an earlier age.

“The approval of this trial in France marks a major milestone to potentially treat one of the world’s most devastating genetic diseases,” added Sheila Mikhail, JD, MBA, CEO and Co-Founder of AskBio.

“If successful, this novel approach for treating Huntington’s Disease may impact how we treat many other neurodegenerative diseases in the future.”

About the BV-101 Clinical Trial
The BV-101 clinical trial will be an open-label, dose-escalation study to assess the safety, tolerability, and preliminary efficacy of administration of BV-101 in adult subjects with early-stage Huntington’s Disease (HD).

The trial will include 12-18 participants and is expected to begin in Paris in Q4, 2022. The trial will be led by principal investigator, Alexandra Durr, MD, PhD, Professor Genetics, Reference Centre for Rare diseases-Neurogenetics.”

https://media.bayer.com/baynews/baynews.nsf/id/BrainVectis-a-subsidiary-AskBio-receives-clearance-conduct-Phase-I-II-clinical-trial-France-novel?Open&parent=news-overview-category-search-en&ccm=020

AstraZeneca aims to transform cancer outcomes with new data across industry-leading portfolio at ESMO 2022

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AstraZeneca aims to transform cancer outcomes with new data across industry-leading portfolio at ESMO 2022

August 24, 2022: “AstraZeneca will present new data supporting its ambition to redefine cancer care at the European Society for Medical Oncology (ESMO) Congress 2022, 9 to 13 September 2022.

A total of 15 approved and potential new medicines from AstraZeneca will be featured across more than 75 abstracts in 13 tumour types.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “At ESMO this year, new evidence will demonstrate how our medicines are prolonging patient survival across several cancers. Data from the SOLO-1 and PAOLA-1 Phase III trials will reinforce the long-term survival benefits of PARP inhibition with Lynparza in advanced ovarian cancer, and new data for Imfinzi combinations in liver, biliary tract and lung cancers will show the potential to improve outcomes for patients in these areas of high unmet need.”

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “The momentum will continue for Enhertu at ESMO with new data across tumour types, including results from the DESTINY-Lung02 Phase II trial in HER2-mutant metastatic non-small cell lung cancer which formed the basis for the recent FDA approval.

Additionally, we’re excited to advance the science of CTLA-4 inhibition with new analyses presented from two Phase III trials of Imfinzi plus tremelimumab, HIMALAYA in liver cancer and POSEIDON in lung cancer, and for MEDI5752, our bispecific antibody targeting both PD-1 and CTLA-4 in lung cancer.”

Transforming outcomes across tumours over time
Mature disease-free survival (DFS) data from the ADAURA Phase III trial will be featured in a late-breaking presentation detailing two years of additional follow-up in patients with early-stage (Stage IB-IIIA) EGFR-mutated non-small cell lung cancer (NSCLC) treated with adjuvant Tagrisso (osimertinib). 

Tagrisso is the only targeted treatment option approved in this setting. The presentation will also report updated results for patterns of recurrence and central nervous system DFS.

A late-breaking presentation will feature landmark five-year overall survival (OS) data from the externally sponsored PAOLA-1 Phase III trial of Lynparza (olaparib) in combination with bevacizumab in 1st-line advanced ovarian cancer, including patients with homologous recombination deficiency (HRD) positive disease.

This is the longest follow up for a PARP inhibitor in combination with standard of care in this setting.

In addition, seven-year OS data from the SOLO1 Phase III trial of Lynparza for 1st-line maintenance therapy in BRCA-mutated (BRCAm) advanced ovarian cancer will be presented. This is the longest follow-up for any PARP inhibitor in newly diagnosed advanced ovarian cancer.

Data will also include updated OS results at two years from the TOPAZ-1 Phase III trial of Imfinzi (durvalumab) plus standard-of-care chemotherapy (gemcitabine plus cisplatin) in 1st-line unresectable or advanced biliary tract cancer, as well as an analysis of immune-mediated adverse events.

TOPAZ-1 is the first Phase III trial to show improved OS with an immunotherapy combination versus chemotherapy alone in this setting.

Extending the benefit of antibody drug conjugates (ADCs) to more patients
Several presentations will demonstrate the clinical potential of Enhertu (trastuzumab deruxtecan) treatment across HER2-targetable lung, gastric and breast cancers.

A late-breaking presentation will feature interim results from the DESTINY-Lung02 Phase II trial investigating Enhertu in patients with HER2-mutant (HER2m) metastatic NSCLC (mNSCLC) who have progressed following one or more systemic therapies. 

Enhertu was recently approved in the US in this setting as the first HER2-directed treatment for these patients. Detailed data will also be shared from the DESTINY-Lung01 Phase II trial, both in this setting and in patients with HER2-overexpressing mNSCLC.

Another presentation will feature updated data from the DESTINY-Gastric02 Phase II trial in HER2-positive metastatic gastric cancer, the first Enhertu trial in Western patients with gastric cancer.

Data will also include a subgroup analysis of the DESTINY-Breast03 Phase III trial of Enhertu by disease history and prior treatments in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane.

Patient-reported outcomes from the DESTINY-Breast04 Phase III trial will also highlight quality of life data for patients treated with Enhertu in HER2-low unresectable and/or metastatic breast cancer. 

Enhertu was recently approved in the US as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer based on this trial.

Additional posters will describe trials evaluating the TROP2-directed ADC datopotamab deruxtecan in patients with hormone-receptor positive, HER2-negative breast cancer (TROPION-Breast01 Phase III trial) and in a platform trial in combination with Tagrisso in patients with advanced NSCLC who have experienced disease progression (ORCHARD Phase II trial).

There are currently no approved TROP2-directed therapies for patients in these settings.

Advancing the science of CTLA-4 inhibition
A new analysis from the positive HIMALAYA Phase III trial will show the impact of viral aetiology on outcomes in unresectable liver cancer for patients treated with a single priming dose of tremelimumab, an anti-CTLA-4 antibody, added to Imfinzi (STRIDE regimen).

In addition, a poster will describe the EMERALD-3 Phase III trial evaluating tremelimumab added to Imfinzi and transarterial chemoembolisation with or without lenvatinib in unresectable liver cancer patients eligible for embolisation.

A late-breaking presentation of the positive POSEIDON Phase III trial in mNSCLC will feature four-year OS outcomes in patients treated with a limited course of tremelimumab added to Imfinzi plus chemotherapy.

Another late-breaking presentation will share initial data for MEDI5752 plus chemotherapy in patients with treatment-naïve Stage IIIB-IV non-squamous NSCLC. MEDI5752 is a novel bispecific antibody that simultaneously targets the immune checkpoint proteins PD-1 and CTLA-4.

Bispecific antibodies are a promising approach in immuno-oncology that combines the potential benefits of two medicines into one antibody without the increased toxicity seen with administration of two separate medicines.

Reinforcing the robust benefits of PARP inhibitors across a broad range of tumour types
In addition to data from PAOLA-1 and SOLO1, an oral presentation will share updated efficacy analyses across biomarker subgroups from the PROpel Phase III trial of Lynparza plus abiraterone in patients with newly diagnosed metastatic castration-resistant prostate cancer (mCRPC) treated with the combination with or without homologous recombination repair (HRR) gene mutations. 

Lynparza is the first PARP inhibitor to demonstrate a significant improvement in radiographic progression-free survival in combination with abiraterone versus abiraterone alone in 1st-line mCRPC irrespective of biomarker status.

Additionally, final OS data will be presented from the MEDIOLA Phase II trial of Lynparza and Imfinzi in germline BRCAm platinum-sensitive relapsed ovarian cancer and from the OPINION Phase IIIB trial of Lynparza maintenance monotherapy in patients with platinum-sensitive relapsed ovarian cancer without a germline BRCA1/BRCA2 mutation.

Data will also include an extended OS analysis from the POLO Phase III trial of Lynparza in germline BRCA-mutated metastatic pancreatic cancer, a disease in which no other PARP inhibitor is approved.

Collaboration in the scientific community is critical to improving outcomes for patients.

AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and datopotamab deruxtecan, and with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza.

Key AstraZeneca presentations during ESMO 2022

Lead authorAbstract titlePresentation details
Antibody drug conjugates
Goto, KTrastuzumab Deruxtecan (T-DXd) in Patients (Pts) With HER2-Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC): Interim Results From the Phase 2 DESTINY-Lung02 TrialPresentation #LBA55Mini Oral Session11 September 202210:15am (CEST)
Ueno, NTPatient-Reported Outcomes (PROs) From DESTINY-Breast04, a Randomized Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) vs Treatment of Physician’s Choice (TPC) in Patients (pts) With HER2-Low Metastatic Breast Cancer (MBC)Presentation #217OProffered Paper Session11 September 20229:30am (CEST)
Ku, GYUpdated Analysis of DESTINY-Gastric02: a Phase 2 Single-Arm Trial of Trastuzumab Deruxtecan (T-DXd) in Western Patients (Pts) With HER2-Positive (HER2+) Unresectable/Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer Who Progressed on or After Trastuzumab-Containing RegimenPresentation #1205MOMini Oral Session10 September 20223:45pm (CEST)
Cortés, JSubgroup Analysis by Disease History and Prior Treatments of Patients (pts) With HER2-Positive (HER2+) Metastatic Breast Cancer (MBC) From DESTINY-Breast03, a Randomized Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) vs Trastuzumab Emtansine (T-DM1)Presentation #236Pe-Poster10 September 2022
Li, BTPhase 2 Trial of Trastuzumab Deruxtecan (T-DXd) in Patients (Pts) With HER2-Mutated (HER2m) Metastatic Non-Small Cell Lung Cancer (NSCLC): Registrational Data From DESTINY-Lung01Presentation #976Pe-Poster12 September 2022
Bardia, ADatopotamab deruxtecan (Dato-DXd), a TROP2 antibody-drug conjugate, vs investigators’ choice of chemotherapy (ICC) in previously-treated, inoperable or metastatic hormone-receptor (HR) positive, HER2-negative (HR+/HER2–) breast cancer: TROPION-Breast01Presentation #274TiPTrial in Progress10 September 2022
De Langen, JORCHARD platform study: osimertinib + datopotamab deruxtecan (Dato-DXd) cohort in patients (pts) with advanced NSCLC (aNSCLC) who have progressed on first-line (1L) osimertinibPresentation #1188TiPTrial in Progress12 September 2022
Immuno-oncology
Johnson, ML.Durvalumab (D) ± tremelimumab (T) + chemotherapy (CT) in 1L metastatic (m) NSCLC: overall survival (OS) update from POSEIDON after median follow-up (mFU) of approximately 4 years (y)Presentation #LBA59Mini Oral Session11 September 202211:05am (CEST)
Ahn, MJMEDI5752 or pembrolizumab (P) plus carboplatin/pemetrexed (CP) in treatment-naïve (1L) non-small cell lung cancer (NSCLC): a Phase 1b/2 trialPresentation #LBA56Mini Oral Session11 September 202210:20am (CEST)
Spicer, JPlatform study of neoadjuvant durvalumab (D) alone or combined with novel agents in patients (pts) with resectable, early-stage non-small-cell lung cancer (NSCLC): pharmacodynamic correlates and circulating tumor DNA (ctDNA) dynamics in the NeoCOAST studyPresentation #929MOMini Oral Session12 September 20223:15pm (CEST)
Oh, DYUpdated overall survival (OS) from the Phase 3 TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+ GC) in patients (pts) with advanced biliary tract cancer (BTC)Presentation #56Pe-Poster12 September 2022
Antonuzzo, LImmune-mediated adverse event (imAE) incidence, timing and association with efficacy in the Phase 3 TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+ GC) in advanced biliary tract cancer (BTC)Presentation #57Pe-Poster12 September 2022
Chan, LSImpact of viral aetiology in the Phase 3 HIMALAYA study of tremelimumab (T) plus durvalumab (D) in unresectable hepatocellular carcinoma (uHCC)Presentation #714Pe-Poster12 September 2022
Özgüroğlu, MPhase 3 trial of durvalumab combined with domvanalimab following concurrent chemoradiotherapy (cCRT) in patients with unresectable stage III NSCLC (PACIFIC-8)Presentation #971TiPTrial in Progress10 September 2022
Abou-Alfa, GKA randomised Phase 3 study of tremelimumab (T) plus durvalumab (D) with or without lenvatinib combined with concurrent transarterial chemoembolisation (TACE) versus TACE alone in patients (pts) with locoregional hepatocellular carcinoma (HCC): EMERALD-3Presentation #727TiPTrial in Progress12 September 2022
DNA damage response
Ray-Coquard, ILFinal overall survival (OS) results from the Phase III PAOLA-1/ENGOT-ov25 trial evaluating maintenance olaparib (ola) plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced ovarian cancer (AOC)Presentation #LBA29Proffered Paper Session9 September 20222:00pm (CEST)
DiSilvestro, POverall survival (OS) at 7-year (y) follow-up (f/u) in patients (pts) with newly diagnosed advanced ovarian cancer (OC) and a BRCA mutation (BRCAm) who received maintenance olaparib in the SOLO1/GOG-3004 trialPresentation #517OProffered Paper Session9 September 20222:10pm (CEST)
Guo, CA Phase (Ph) I/II trial of the CXCR2 antagonist AZD5069 in combination with enzalutamide (ENZA) in patients (pts) with metastatic castration resistant prostate cancer (mCRPC)Presentation #454OProffered Paper Session10 September 202211:15am (CEST)
Saad, FBiomarker analysis and updated results from the Phase III PROpel trial of abiraterone (abi) and olaparib (ola) vs abi and placebo (pbo) as first-line (1L) therapy for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)Presentation #1357OProffered Paper Session11 September 20229:30am (CEST)
Banerjee, SPhase II study of olaparib plus durvalumab with or without bevacizumab (MEDIOLA): final analysis of overall survival in patients with non-germline BRCA-mutated platinum-sensitive relapsed ovarian cancerPresentation #529MOMini Oral Session11 September 20225:00pm (CEST)
Poveda Velasco, AMMaintenance olaparib monotherapy in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSR OC) without a germline BRCA1/BRCA2 mutation (non-gBRCAm): final overall survival (OS) results from the OPINION trialPresentation #531Pe-Poster11 September 2022
Hammel, PExtended overall survival results from the POLO study of active maintenance olaparib in patients with metastatic pancreatic cancer and a germline BRCA mutationPresentation #1298Pe-Poster12 September 2022
Tumour drivers and resistance
Tsuboi, MOsimertinib as adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC): updated results from ADAURAPresentation #LBA47Proffered Paper Session11 September 20228:30am (CEST)
Piotrowska, ZELIOS: A multicentre, molecular profiling study of patients (pts) with epidermal growth factor receptor-mutated (EGFRm) advanced NSCLC treated with first-line (1L) osimertinibPresentation #LBA53Proffered Paper Session11 September 20223:05pm (CEST)
Nakamura, AFinal results and biomarker analysis of a randomized phase II study of osimertinib plus bevacizumab versus osimertinib monotherapy for untreated patients with non-squamous non-small-cell lung cancer harboring EGFR mutations; WJOG9717L studyPresentation #982Pe-Poster12 September 2022

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2022/astrazeneca-aims-to-transform-cancer-outcomes-with-new-data-across-industry-leading-portfolio-at-esmo-2022.html

BMS Completes Acquisition of Turning Point Therapeutics, Expanding Precision Oncology Portfolio

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BMS Completes Acquisition of Turning Point Therapeutics, Expanding Precision Oncology Portfolio

AUG 17, 2022: “Bristol Myers Squibb  announced that it has successfully completed its acquisition of Turning Point Therapeutics, Inc. (“Turning Point”), in an all-cash transaction.

With the completion of the acquisition, Turning Point shares have ceased trading on the NASDAQ Global Select Market and Turning Point is now a wholly owned subsidiary of Bristol Myers Squibb.

“Turning Point has distinguished itself in the field of precision oncology, and this acquisition will further strengthen our leading oncology franchise,” said Elizabeth Mily, Executive Vice President, Strategy & Business Development, Bristol Myers Squibb.

“With Turning Point’s lead asset, repotrectinib, Bristol Myers Squibb will be positioned to address a significant unmet medical need for ROS1-positive non-small cell lung cancer patients.

We look forward to bringing this promising, innovative medicine to patients in the second half of 2023.”

Through the transaction, Bristol Myers Squibb gains a pipeline of investigational medicines designed to target the most common mutations associated with oncogenesis, including repotrectinib.

Repotrectinib is a next-generation, potential best-in-class tyrosine kinase inhibitor targeting the ROS1 and NTRK oncogenic drivers of non-small cell lung cancer (NSCLC) and other advanced solid tumors.

In the Phase 1/2 TRIDENT-1 clinical trial, longer duration of response has been observed in the landmark analysis with repotrectinib than with existing ROS1 agents in first-line NSCLC.

The asset has been granted three Breakthrough Therapy Designations from the U.S. Food and Drug Administration.

Bristol Myers Squibb expects repotrectinib to be approved in the U.S. in the second half of 2023 and become a new standard of care for patients with ROS1-positive NSCLC in the first-line setting.

Bristol Myers Squibb also plans to continue to explore the potential of Turning Point’s promising pipeline of novel compounds.

Bristol Myers Squibb’s previously announced tender offer for all outstanding shares of common stock of Turning Point for $76.00 per share expired at 5:00 p.m. Eastern Time on August 15, 2022.

Approximately 41,896,678 shares of Turning Point common stock were validly tendered, and not validly withdrawn from the tender offer, representing approximately 84% of Turning Point’s issued and outstanding shares of common stock.

In accordance with the terms of the tender offer, all shares that were validly tendered and not validly withdrawn have been accepted for payment and Bristol Myers Squibb expects to promptly pay for all such shares.

Following completion of the tender offer, Bristol Myers Squibb completed the acquisition of Turning Point through the merger of its wholly owned subsidiary, Rhumba Merger Sub Inc., with and into Turning Point, without a vote of Turning Point’s stockholders pursuant to Section 251(h) of the General Corporation Law of the State of Delaware.

As a result of the merger, each share of common stock of Turning Point issued and outstanding and not tendered in the tender offer was automatically converted into the right to receive an amount in cash equal to $76.00, without interest, subject to any applicable withholding of taxes, the same price offered in the tender offer.

Turning Point shareholders can direct questions regarding the tender offer to MacKenzie Partners, Inc., the information agent for the tender offer, toll free, at 1-800-322-2885.”

https://investors.bms.com/iframes/press-releases/press-release-details/2022/Bristol-Myers-Squibb-Completes-Acquisition-of-Turning-Point-Therapeutics-Expanding-Precision-Oncology-Portfolio/default.aspx

Mirena® from Bayer approved in the US for extended duration of use in contraception

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Mirena® from Bayer approved in the US for extended duration of use in contraception

August 18, 2022: “Bayer, a leader in women’s healthcare, announced today that the supplemental New Drug Application (sNDA) for the extended use up to eight years in the indication, contraception was approved for its levonorgestrel (LNG) releasing intrauterine system (IUS) Mirena® by the U.S.FDA.

This approval is based on the results of the Mirena Extension Trial evaluating the efficacy and safety of Mirena which demonstrated that contraceptive efficacy during years six to eight remains high.

“This label extension underlines Bayer’s continued commitment to drive innovation in the area of women’s healthcare and to offer women a broad variety of contraceptive methods during their reproductive life”, said Dr. Michael Devoy, Chief Medical Officer at Bayer AG.

“As every woman is different, the personal decision for a specific contraceptive option is taken on the individual needs of a woman in close consultation with her healthcare professional.”

The duration of use for the second approved indication in the US (heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception) remains unchanged for up to five years.

At the beginning of 2022, Bayer also submitted the eight-year label extension for the indication contraception in the EU for the LNG-IUS Mirena.

LNG-IUS is one of the most effective birth control methods as it does not require user interventions such as daily dosing or monthly re-fills.

It can be removed by the doctor at any time and offers a rapid return to a woman’s natural level of fertility after removal. An LNG-IUS should only be inserted after a comprehensive discussion and evaluation of all contraceptive options and the individual woman’s needs.

About the Contraceptive Efficacy & Mirena Extension Trial
The contraceptive efficacy of Mirena for up to five years has been studied in five large clinical trials involving 3,330 women.

The Pearl Index was about 0.2 in the first year and cumulatively, contraception failed by about 0.7% over five years.

The contraceptive effectiveness of Mirena after more than five years (including years six to eight) was studied in the Mirena Extension Trial.

Based on 2 pregnancies (1 in Year 6 and 1 in Year 7) and 10,216 exposure cycles, the cumulative pregnancy rate at the end of the 3-year period of extended use (Years 6, 7 and 8) was 0.68% with a 95% upper confidence limit of 2.71%.

The study confirmed a positive benefit risk profile with no new or unexpected safety findings. The eight-year data from the extension trial were published in abstract form at the American College of Obstetricians and Gynecologists (ACOG) in 2022.

The full paper will be published in due course. Information about this trial can be found at https://clinicaltrials.gov/ct2/show/study/NCT02985541.

About Mirena®
Mirena is a T-shaped device containing 52 mg of synthetic levonorgestrel. Once placed in the uterus, it continuously releases small amounts of levonorgestrel directly into the uterus. Mirena is available in many countries over all continents.

The approved indications in the US are contraception (prevention of pregnancy) for up to eight years of use and treatment of heavy menstrual bleeding for women who choose to use intrauterine contraception as their method of contraception for up to five years.

Mirena is a long-acting reversible contraceptive (LARC) and can be removed at any time by a healthcare provider if a woman’s plans change.

About Women’s Healthcare at Bayer
Bayer is a recognized leader in the area of women’s healthcare, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide.

Today, Bayer’s research and development efforts focus on finding new treatment options for menopause as well as gynecological diseases and includes several compounds in various stages of pre-clinical and clinical development.

Together, these projects reflect the company’s approach to research, which prioritizes targets and pathways with the potential to alter the way that gynecological diseases are treated.

Additionally, Bayer intends to provide 100 million women in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs and by ensuring the supply of affordable modern contraceptives.

This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.”

https://media.bayer.com/baynews/baynews.nsf/id/Mirena-from-Bayer-approved-in-the-US-for-extended-duration-of-use-in-contraception?OpenDocument&sessionID=1661144809

FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies

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FDA Warns Manufacturer for Marketing Illegal Flavored Nicotine Gummies

August 18, 2022: “The U.S. FDA issued a warning letter for marketing illegal flavored nicotine gummies – the first warning letter for this type of product.

These types of gummies are of particular public concern because of their resemblance to kid-friendly food or candy products and the potential to cause severe nicotine toxicity or even death among young children.

The manufacturer, VPR Brands LP (doing business as, “Krave Nic”), markets gummies that have 1 milligram (mg) of nicotine each and are available in three flavors – Blueraz, Cherry Bomb and Pineapple.

The packaging claims that the products contain tobacco-free nicotine.

This firm has not submitted a premarket tobacco product application (PMTA) to the FDA, and does not have a marketing authorization order to manufacture, sell or distribute these products in the U.S.

“Nicotine gummies are a public health crisis just waiting to happen among our nation’s youth, particularly as we head into a new school year,” said FDA Commissioner Robert M. Califf, M.D.

“We want parents to be aware of these products and the potential for health consequences for children of all ages – including toxicity to young children and appeal of these addictive products to our youth.

The FDA will not stand by as illegal products infiltrate the marketplace.”

The manufacturer states that each gummy contains 1 milligram of nicotine with 12 gummies (12 mg) per tin. Research indicates that ingesting 1 to 4 milligrams of nicotine could be severely toxic to a child under 6 years of age depending on the child’s body weight.

However, nicotine toxicity among youth of any age may lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death.

Nicotine is also highly addictive and exposure during adolescence can harm the developing brain.

In a recent study published in the journal PediatricsExternal Link Disclaimer, researchers found that flavored non-tobacco oral nicotine products, including gummies and lozenges, were among the most commonly used tobacco product among youth in southern California – second only to e-cigarettes.

Use was particularly high among certain racial or ethnic, sexual or gender minority groups, and those with a history of nicotine use.

These flavored non-tobacco oral nicotine products present an increased risk to youth due to their resemblance to kid-friendly food or candy products, such as gummies or gum, the availability in youth-appealing flavors, and the ability for teenagers to conceal use from adults. 

The warning letter issued today requests a written response from the manufacturer describing how the firm intends to address any violations and bring their products into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Failure to promptly correct violations can result in further action such as civil money penalties, seizure, and/or injunction.

Additionally, the firm must not sell or distribute violative products. The firm must submit a PMTA and receive marketing authorization from FDA before selling or distributing the product in the U.S.

In response to the increase of non-tobacco nicotine in tobacco products, including in some of the e-cigarette brands that are most popular with youth, Congress passed a federal law that went into effect on April 14, 2022, clarifying the FDA’s authority to regulate tobacco products containing nicotine from any source.

This law gives the FDA authority over products made with non-tobacco nicotine, including synthetic nicotine, and imposes requirements under the FD&C Act for manufacturers, importers, retailers and distributors of non-tobacco nicotine products.

To date, no non-tobacco nicotine product has received a marketing granted order. 

“We remain unwavering in our use of compliance and enforcement resources to curb all unlawful marketing of tobacco products, especially those that youth could easily confuse with something that they consume regularly – like candy,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products.

“Today’s action should be a wake-up call for manufacturers of these illegal products that the FDA is actively working to identify violations and to swiftly seek corrective actions.”

Efforts such as these support the FDA’s commitment to using a science-based approach to protect youth from initiating tobacco use. In addition to the FDA’s regulatory oversight, the agency recognizes the critical need for targeted youth tobacco prevention efforts designed to protect America’s kids, including mass media campaigns such as “The Real Cost.” ‘

The FDA also collaborates with the Centers for Disease Control and Prevention on the National Youth Tobacco Survey, the only nationally representative survey of middle and high school students that focuses exclusively on tobacco product use. 

https://www.fda.gov/news-events/press-announcements/fda-warns-manufacturer-marketing-illegal-flavored-nicotine-gummies

FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

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FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

August 16, 2022: “the U.S. Food and Drug Administration issued a final rule to improve access to hearing aids which may in turn lower costs for millions of Americans.

This action establishes a new category of over-the-counter (OTC) hearing aids, enabling consumers with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist. 

The rule is expected to lower the cost of hearings aids, furthering the Biden-Harris Administration’s goal of expanding access to high-quality health care and lowering health care costs for the American public.

It is designed to assure the safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace. 

Today’s action follows President Biden’s Executive Order on Promoting Competition in the American Economy, which called for the FDA to take steps to allow hearing aids to be sold over the counter and set a swift 120-day deadline for action, which the FDA met.

In 2017, Congress passed bipartisan legislation requiring the FDA to create a category of OTC hearing aids, but it was not fully implemented until now.

Consumers could see OTC hearing aids available in traditional retail and drug stores as soon as mid-October when the rule takes effect.

“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra.

“Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

Close to 30 million adults in the U.S. could benefit from hearing aid use. Individuals with permanent hearing impairment can use hearing aids to help make speech and sounds louder, improving the ability to communicate effectively with others.

Many hearing aids can be expensive.

The final rule aims to stimulate competition and facilitate the sale of safe and effective OTC hearing aids in traditional retail stores or online nationwide, providing consumers with perceived mild to moderate hearing loss with improved access to devices that meet their needs and are less expensive than current options. 

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M. Califf, M.D.

“Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”   

The OTC category established in this final rule applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment.

Hearing aids that do not meet the requirements for the OTC category (for example, because they are intended for severe hearing impairment or users younger than age 18) are prescription devices. 

The FDA finalized the rule after receiving and reviewing more than 1,000 public comments on the proposed rule issued on Oct. 20, 2021.

Comments submitted by consumers, professional associations, hearing aid manufacturers, public health organizations and advocacy groups, members of Congress, state agencies, and other stakeholders are summarized in the final rule, along with the FDA’s respective responses.

In response to public comments and to assure the safety and effectiveness of OTC hearing aids, the final rule incorporates several changes from the proposed rule, including lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the phrasing throughout the required device labeling to ensure it is easily understood.

The final rule also includes performance specifications and device design requirements specific to OTC hearing aids.

Furthermore, today’s action correspondingly amends existing rules that apply to prescription hearing aids for consistency with the new OTC category, it repeals the conditions for sale for hearing aids, and it includes provisions that address some of the effects of the FDA OTC hearing aid regulations on state regulation of hearing aids.

Concurrently with issuing the final rule, the FDA also issued the final guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs), to clarify the differences between hearing aids, which are medical devices, and PSAPs, consumer products that help people with normal hearing amplify sounds.  

The effective date for the final rule is 60 days following publication in the Federal Register.

Manufacturers of hearing aids sold prior to the effective date of the final rule will have 240 days after its publication to comply with the new or revised requirements.

For hearing aids that have not been offered for sale prior to the effective date, compliance with the new or revised requirements must be achieved before marketing the device, including obtaining 510(k) clearance if applicable.”

https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans

Sanofi provides update on amcenestrant clinical development program

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Sanofi provides update on amcenestrant clinical development program

August 17, 2022: “Sanofi is discontinuing the global clinical development program of amcenestrant, an investigational oral selective estrogen receptor degrader (SERD).

The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial evaluating amcenestrant in combination with palbociclib compared with letrozole in combination with palbociclib in patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer.

An Independent Data Monitoring Committee (IDMC) found that amcenestrant in combination with palbociclib did not meet the prespecified boundary for continuation in comparison with the control arm and recommended stopping the trial. No new safety signals were observed.

Trial participants will be transitioned to letrozole in combination with palbociclib or another appropriate standard of care therapy, as determined by their physician.

The company will continue to review the data and plans to share the results with the scientific community in the future. All other studies of amcenestrant, including in early-stage breast cancer (AMEERA-6), will be discontinued.

John Reed, MD, PhD
Global Head of Research and Development at Sanofi
“While we are disappointed by this outcome, our research will further the scientific understanding of endocrine therapies in people with breast cancer. 

Our sincere gratitude goes to the patients, families and healthcare professionals involved in the amcenestrant clinical development program. 

Oncology remains a priority area for Sanofi, and we will continue to pursue transformative research to develop new medicines for people living with cancer.”

In March, Sanofi announced that the Phase 2 AMEERA-3 trial had not met the primary endpoint of improving progression-free survival in patients with ER+/HER2- advanced or metastatic breast cancer.

About AMEERA-5
AMEERA-5 is a randomized, double-blind Phase 3 trial evaluating the efficacy and safety of amcenestrant in combination with palbociclib, a CDK4/6 inhibitor, in the first-line treatment of patients with ER+/HER2- advanced breast cancer.

A total of 1068 patients who had not received any prior systemic anticancer therapies for advanced disease were randomized 1:1 to receive either amcenestrant or letrozole in combination with palbociclib.

About AMEERA-6
AMEERA-6 is a randomized, double-blind Phase 3 trial evaluating the efficacy and safety of amcenestrant compared with tamoxifen in patients with hormone receptor-positive early breast cancer who have discontinued adjuvant aromatase inhibitor (AI) therapy due to treatment related toxicity.

The trial was initiated in partnership with the Breast International Group (BIG), the European Organization for Research and Treatment of Cancer (EORTC), and the Alliance Foundation Trials (AFT).”

https://www.sanofi.com/en/media-room/press-releases/2022/2022-08-17-05-30-00-2499668

Novartis provides update on Phase III CANOPY for NSCLC

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Novartis provides update on Phase III CANOPY for NSCLC

August 15, 2022: “Novartis announced that the Phase III CANOPY-A study evaluating adjuvant treatment with canakinumab (ACZ885), an inhibitor of interleukin-1beta (IL-1β), in adult patients with stages II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC) did not meet its primary endpoint of disease-free survival (DFS) versus placebo.

No unexpected safety signals were observed.

Findings from the trial will be presented at an upcoming medical meeting.

“We made an investment in the CANOPY program based on signals of reduced lung cancer incidence and mortality observed in the CANTOS study.

These positive signals supported the study of canakinumab as adjuvant treatment for early lung cancer,” said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis.

“While we are disappointed CANOPY-A did not show the benefit we hoped for, every trial generates scientific evidence that supports future research and development, and we look forward to continuing to pursue new therapeutic options for people living with lung cancer, whose needs remain urgent and significant.

We thank the patients and clinical investigators whose time and commitment made this research possible.”

CANOPY-A is a Phase III, multicenter, randomized, double blind study that is evaluating the efficacy and safety of canakinumab as adjuvant treatment in patients with NSCLC stages II-IIIA and IIIB (T>5cm N2), per American Joint Committee on Cancer/The Union for International Cancer Control (AJCC/UICC) 8th edition staging, whose margins are free of cancer following surgery.

In the trial, 1,382 patients were randomized 1:1 to canakinumab, 200 mg subcutaneously every three weeks, or matching placebo for up to one year.

Patients completed standard-of-care adjuvant cisplatin-based chemotherapy and radiation therapy, if applicable, prior to randomization.

About canakinumab (ACZ885) 
Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to human IL-1β and inhibits IL-1β activity by blocking its interaction with its receptors.

By inhibiting IL-1β, preliminary evidence suggests that canakinumab may suppress Pro-Tumor Inflammation to 1) enhance anti-tumor immune response; 2) reduce tumor cell proliferation, survival and invasiveness; and 3) impair angiogenesis. 

Pro-Tumor Inflammation enables tumor development by driving cancer-causing processes and suppressing anti-tumor immune responses.

About the CANOPY program 
Novartis launched the CANOPY study program after observing significantly lower than expected rates of lung cancer mortality among patients in the Phase III cardiovascular CANTOS trial.

The CANTOS trial evaluated canakinumab as a secondary prevention measure for cardiovascular events in patients following a heart attack.

Patients in the CANTOS trial also were at high risk for inflammatory cancers like lung cancer due to advanced age, smoking history, and other clinical risk factors.

Based on these findings, Novartis launched three large-scale, randomized, Phase III clinical trials and a Phase II clinical trial to investigate canakinumab as a potential treatment option in NSCLC.

Novartis and lung cancer
Lung cancer is one of the most common cancers worldwide, accounting for more than 2 million new cases diagnosed each year.

More people die of lung cancer every year than any other cancer.

There are two main types of lung cancer—small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC).

NSCLC accounts for approximately 85% of lung cancer diagnoses, and 30-55% of patients with early NSCLC develop recurrence despite resection.

Novartis is committed to working with the scientific and medical communities to reimagine the treatment of lung cancer and pursue advances in medicine that could extend the survival of people living with lung cancer. 

Novartis is developing experimental therapies that block cancer growth; learning more about ways to activate the body’s immune system; increasing understanding of the relationship between chronic inflammation and tumor growth and progression; and exploring the potential for advanced nuclear medicine to fight the disease.”

https://www.novartis.com/news/media-releases/novartis-provides-update-phase-iii-canopy-study-evaluating-canakinumab-adjuvant-treatment-non-small-cell-lung-cancer

Monkeypox: experts give virus variants new names

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Monkeypox: experts give virus variants new names

August 12, 2022: “A group of global experts convened by WHO has agreed on new names for monkeypox virus variants, as part of ongoing efforts to align the names of the monkeypox disease, virus and variants—or clades—with current best practices.

The experts agreed to name the clades using Roman numerals.

The monkeypox virus was named upon first discovery in 1958, before current best practices in naming diseases and viruses were adopted. Similarly for the name of the disease it causes.

Major variants were identified by the geographic regions where they were known to circulate.

Current best practise is that newly-identified viruses, related disease, and virus variants should be given names with the aim to avoid causing offense to any cultural, social, national, regional, professional, or ethnic groups, and minimize any negative impact on trade, travel, tourism or animal welfare.

Disease: Assigning new names to existing diseases is the responsibility of WHO under the International Classification of Diseases and the WHO Family of International Health Related Classifications (WHO-FIC).

WHO is holding an open consultation for a new disease name for monkeypox. Anyone wishing to propose new names can do so here (see ICD-11, Add proposals).

Virus: The naming of virus species is the responsibility of the International Committee on the Taxonomy of Viruses (ICTV), which has a process underway for the name of the monkeypox virus. 

Variants/clades: The naming of variants for existing pathogens is normally the result of debate amongst scientists.

In order to expedite agreement in the context of the current outbreak, WHO convened an ad hoc meeting on 8 August to enable virologists and public health experts to reach consensus on new terminology.

Experts in pox virology, evolutionary biology and representatives of research institutes from across the globe reviewed the phylogeny and nomenclature of known and new monkeypox virus variants or clades.

They discussed the characteristics and evolution of monkeypox virus variants, their apparent phylogenetic and clinical differences, and potential consequences for public health and future virological and evolutionary research.

The group reached consensus on new nomenclature for the virus clades that is in line with best practices.

They agreed on how the virus clades should be recorded and classified on genome sequence repository sites.

Consensus was reached to now refer to the former Congo Basin (Central African) clade as Clade one (I) and the former West African clade as Clade two (II). Additionally, it was agreed that the Clade II consists of two subclades.

The proper naming structure will be represented by a Roman numeral for the clade and a lower-case alphanumeric character for the subclades.

Thus, the new naming convention comprises Clade I, Clade IIa and Clade IIb, with the latter referring primarily to the group of variants largely circulating in the 2022 global outbreak.

The naming of lineages will be as proposed by scientists as the outbreak evolves. Experts will be reconvened as needed.”

https://www.who.int/news/item/12-08-2022-monkeypox–experts-give-virus-variants-new-names

FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply

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FDA Authorizes Emergency Use of JYNNEOS Vaccine to Increase Vaccine Supply

August 09, 2022: “The U.S. FDA issued an emergency use authorization for the JYNNEOS vaccine to allow healthcare providers to use the vaccine by intradermal injection for individuals 18 years of age and older who are determined to be at high risk for monkeypox infection.

This will increase the total number of doses available for use by up to five-fold.

The EUA also allows for use of the vaccine in individuals younger than 18 years of age determined to be at high risk of monkeypox infection; in these individuals JYNNEOS is administered by subcutaneous injection.

“In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand,” said FDA Commissioner Robert M. Califf, M.D.

“The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals.

By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so.” 

JYNNEOS, the Modified Vaccinia Ankara (MVA) vaccine, was approved in 2019 for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.

JYNNEOS is administered beneath the skin (subcutaneously) as two doses, four weeks (28 days) apart.

For individuals 18 years of age and older determined to be at high risk of monkeypox infection, the EUA now allows for a fraction of the JYNNEOS dose to be administered between the layers of the skin (intradermally).

Two doses of the vaccine given four weeks (28 days) apart will still be needed.

There are no data available to indicate that one dose of JYNNEOS will provide long-lasting protection, which will be needed to control the current monkeypox outbreak. 

Data from a 2015 clinical study of the MVA vaccine evaluated a two-dose series given intradermally compared to subcutaneously.

Individuals who received the vaccine intradermally received a lower volume (one fifth) than individuals who received the vaccine subcutaneously.

The results of this study demonstrated that intradermal administration produced a similar immune response to subcutaneous administration, meaning individuals in both groups responded to vaccination in a similar way.

Administration by the intradermal route resulted in more redness, firmness, itchiness and swelling at the injection site, but less pain, and these side effects were manageable.

The FDA has determined that the known and potential benefits of JYNNEOS outweigh the known and potential risks for the authorized uses.

To support the FDA’s authorization of two doses of JYNNEOS administered by the subcutaneous route of administration in individuals younger than 18 years of age, the FDA considered the available JYNNEOS safety and immune response data in adults as well as the historical data with use of live vaccinia virus smallpox vaccine in pediatric populations.

JYNNEOS has been tested in individuals with immunocompromising conditions and has been found to be safe and effective in the trials that were performed to support approval.

It was initially developed specifically as an alternative for use in immunocompromised individuals in the event of a smallpox outbreak.

On the basis of the determination by the Secretary of the Department of Health and Human Services on Aug. 9, 2022, that there is a public health emergency, or the significant potential for a public health emergency, that has a significant potential to affect national security or the health and security of United States citizens living abroad, and the declaration on Aug. 9, 2022, that circumstances exist justifying the emergency use of vaccines, the FDA may issue an EUA to allow emergency use of unapproved vaccines or unapproved uses of approved vaccines.

The FDA will provide updates as developments occur and will continue to work with federal public health partners and industry to ensure timely access to all available medical countermeasures.”

https://www.fda.gov/news-events/press-announcements/monkeypox-update-fda-authorizes-emergency-use-jynneos-vaccine-increase-vaccine-supply

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