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FDA OK’s TAUVID™ for Use in Patients Evaluated for Alzheimer’s Disease

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FDA OK’s TAUVID™ for Use in Patients Evaluated for Alzheimer’s Disease
May 28, 2020: “TAUVID™, a radioactive diagnostic agent, has been approved by the FDA for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD).

Neuropathological diagnosis of AD requires the demonstration of the presence of both beta-amyloid neuritic plaques and tau NFTs in the brain.

TAUVID is the first and only approved diagnostic agent to image tau NFTs in the brain. Avid Radiopharmaceuticals, Inc., a wholly-owned subsidiary of Eli Lilly and Company (NYSE: LLY), developed TAUVID and AMYVID® (Florbetapir F 18 Injection) to provide physicians with meaningful information on the presence of both pathologies to aid the evaluation of patients suspected of having AD.

“The use of diagnostic imaging can help patients and their families plan for the future and make informed choices about their health and well-being, in addition to facilitating appropriate patient management for physicians,” said Reisa Sperling, M.D., Professor of Neurology of Harvard Medical School, and Director of the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital and Massachusetts General Hospital.

“Determining the anatomic distribution and density of tau NFTs in the brain was previously possible only at autopsy. Now we have a way to obtain this important information in patients.”

TAUVID was evaluated in two clinical studies. In Study 1, reader interpretations of premortem TAUVID scans from 64 cognitively normal and impaired terminally ill patients who agreed to undergo TAUVID imaging and to participate in a postmortem brain donation program were compared to tau pathology at autopsy based on scoring provided by independent pathologists blinded to scan results.

This study met its pre-specified success criteria, with reader sensitivity (95% CI) ranging from 92% (80, 97) to 100% (91, 100) and specificity (95% CI) from 52% (34, 70) to 92% (75, 98) in the primary efficacy cohort.

In Study 2, images from the same terminally ill patients as in Study 1 (plus 18 additional terminally ill patients) and 159 patients with cognitive impairment being evaluated for AD (the indicated population) were evaluated by 5 new readers.

This study also met the prespecified success criteria for comparison of TAUVID reads to NFT pathology. In addition, inter-reader agreement was evaluated using Fleiss’ kappa statistic and found to be 0.87 (95% CI: 0.83, 0.91) across 241 patients in Study 2.

The most common adverse reactions reported in clinical trials were headache (1.4%), injection site pain (1.2%), and increased blood pressure (0.8%).1,3

“The fight against AD requires precise and reliable assessments of the two key pathologies of the disease because clinical assessments alone are limited in their ability to accurately diagnose patients,” said Mark Mintun, M.D., vice president of Lilly’s pain and neurodegeneration research and development.

“History was made with the FDA approval of AMYVID to demonstrate the presence of one of those two pathologies, beta-amyloid plaques.

I am excited that TAUVID has now been approved to image tau NFTs, which is the other key pathology, allowing a more comprehensive evaluation of patients. 

Lilly and Avid Radiopharmaceuticals are committed to bringing innovative AD diagnostics to the patients who need them most.”

Availability of TAUVID will initially be limited and will expand in response to commercial demand and payor reimbursement. 

Lilly remains committed to patients with cognitive impairment associated with Alzheimer’s disease and to ensuring patient access to this innovative diagnostic tool. 

Lilly is supportive of policies that will provide access and coverage for beta-amyloid PET and tau PET imaging agents. 

For more than 30 years, Lilly has been engaged in bringing innovative Alzheimer’s disease therapies and diagnostics to patients and continues to lead the field in research, which also includes identifying biomarkers to support early detection of the disease.


Limitations of Use
TAUVID is not indicated for use in the evaluation of patients for chronic traumatic encephalopathy (CTE).


Adverse Reactions
The most common adverse reactions reported in clinical trials were headache (1.4%), injection site pain (1.2%), and increased blood pressure (0.8%).”

https://investor.lilly.com/news-releases/news-release-details/lilly-receives-us-fda-approval-tauvidtm-flortaucipir-f-18

GSK to produce1 billion doses of pandemic vaccine adjuvant

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GSK to produce1 billion doses of pandemic vaccine adjuvant
May 28, 2020: “GSK confirmed its intention to manufacture 1 billion doses of its pandemic vaccine adjuvant system, in 2021, to support the development of multiple adjuvanted COVID-19 vaccine candidates.

GSK believes that its pandemic adjuvant technology could make a significant contribution against COVID-19.  

As demonstrated in the last flu pandemic, GSK’s pandemic adjuvant can reduce the amount of vaccine protein required per dose, which allows more vaccine doses to be produced, contributing to protecting more people.

Additionally, an adjuvant can enhance the immune response and has been shown to create a stronger and longer-lasting immunity against infections.

GSK has prioritised its efforts towards making its pandemic adjuvant technology available to partners developing promising COVID-19 vaccine candidates that are suitable for use with an adjuvant.

To date, the company has formed several collaborations, including with scientific partners in North America, Europe and China, to develop vaccines. Discussions with potential partners on further collaborations are ongoing.

Confirmation of the enhanced manufacturing capacity follows completion of a review conducted across the company’s global supply network. GSK will manufacture, fill and finish adjuvant for use in COVID-19 vaccines at sites in the UK, US, Canada and Europe.

Roger Connor, President, GSK Global Vaccines, said: “We believe that more than one vaccine will be needed to address this global pandemic and we are working with partners around the world to do so.

We believe that our innovative pandemic adjuvant technology has the potential to help improve the efficacy and scale up of multiple COVID-19 vaccines.

With this significant expansion in our manufacturing capacity, we can help deliver up to 1 billion doses of adjuvanted vaccines through 2021, helping protect many more people and support the global effort to fight COVID-19.”

Given the unprecedented need to develop COVID-19 vaccines, GSK has started manufacture of the adjuvant at risk.

The company is in discussions with Governments and global institutions about funding for production and supply of the adjuvant.

GSK is committed to making its adjuvant available through mechanisms that offer fair access for people across the world.

Making the adjuvant available to the world’s poorest countries will also be a key part of these efforts, including donations, by working with governments and the global institutions that prioritise access.

Overall GSK does not expect to profit from sales of its portfolio of collaborations for COVID-19 vaccines made during this pandemic phase, as profit generated will be invested in support of coronavirus related research and long-term pandemic preparedness, either through GSK’s internal investments, or with external partners.”

https://www.gsk.com/en-gb/media/press-releases/gsk-announces-intention-to-produce-1-billion-doses-of-pandemic-vaccine-adjuvant/

Tagrisso demonstrated unprecedented disease-free survival in lung cancer

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Tagrisso demonstrated unprecedented disease-free survival in lung cancer
May 28, 2020: “Detailed results from the Phase III ADAURA trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.

Results will be presented during the plenary session of the American Society of Clinical Oncology ASCO20 Virtual Scientific Program on 31 May (abstract #LBA5).

In the primary endpoint of DFS in patients with Stage II and IIIA disease, adjuvant treatment (after surgery) with Tagrisso reduced the risk of disease recurrence or death by 83% (based on a hazard ratio [HR] of 0.17; 95% confidence interval [CI] 0.12, 0.23; p<0.0001).

DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001).


More Related News: Tagrisso Phase III ADAURA trial will be unblinded early after overwhelming efficiency in the adjuvant treatment of the patients with EGFR-mutated lung cancer

At two years, 89% of patients in the trial treated with Tagrisso remained alive and disease free versus 53% on placebo.

Consistent DFS results were seen across all subgroups, including patients who were treated with surgery followed by chemotherapy and those who received surgery only, as well as in Asian and non-Asian patients.

Roy S. Herbst, MD, Ph.D., chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, CT and principal investigator in the Phase III ADAURA trial, said: “These data are transformative for patients with early-stage EGFR-mutated non-small cell lung cancer who face high rates of recurrence even after successful surgery and subsequent treatment with adjuvant chemotherapy. 

Tagrisso will provide a much-needed new treatment option that has the potential to change the practice of medicine and improve outcomes for patients in this setting.”

José Baselga, Executive Vice President, Oncology R&D, said: “The momentous results of the Phase III ADAURA trial for Tagrisso demonstrate for the first time in a global trial that an EGFR inhibitor can change the course of early-stage EGFR-mutated lung cancer and provide hope for a cure.

We are discussing these outstanding data with regulatory authorities and look forward to bringing the benefits of Tagrisso to patients with early-stage disease.”

In April 2020, an Independent Data Monitoring Committee recommended for the Phase III ADAURA trial to be unblinded two years early based on its determination of overwhelming efficacy.

At the time of data cut-off, overall survival (OS) data favoured Tagrisso, but were not mature. The trial will continue to assess OS as a secondary endpoint.

Summary of ADAURA results
The safety and tolerability of Tagrisso in this trialwas consistent with previous trials in the metastatic setting. Adverse events at Grade 3 or higher from all causes occurred in 10% of patients in the Tagrisso arm versus 3% in the placebo arm as assessed by the investigator.

Tagrisso is approved for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC in the US, Japan, China, the EU and many other countries around the world.

Several presentations featured during the ASCO20 Virtual Scientific Program will showcase AstraZeneca’s leadership in lung cancer across early and late-stage disease and reinforce the Company’s biomarker-driven approach.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/tagrisso-demonstrated-unprecedented-disease-free-survival-in-the-adjuvant-treatment-of-stage-ib-iiia-patients-with-egfr-mutated-lung-cancer.html

Roche’s Alecensa increases the overall survival rate for people with ALK-positive non-small cell lung cancer

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Roche’s Alecensa increases the overall survival rate for people with ALK-positive non-small cell lung cancer

May 29, 2020: Roche presented updated data from the pivotal phase III ALEX study, showing an increased five-year survival rate with Alecensa® (alectinib), compared with crizotinib, in people living with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

These data confirm the longer-term efficacy of Alecensa already demonstrated across three phase III clinical trials. Full findings were presented at the ASCO20 Virtual Scientific Programme, on 29 May 2020.

“These data further support Alecensa as the standard of care for people with metastatic ALK-positive NSCLC,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.

“Importantly, these data show clinically meaningful benefit in people with or without central nervous system (CNS) metastases. These data, and our work in lung cancer more broadly, demonstrate our continued commitment to improving outcomes for people with this disease.”

The updated results from the ALEX study show a five-year survival rate of 62.5% (95% CI: 54.3-70.8) in the Alecensa treatment group, versus 45.5% (95% CI: 33.6-57.4) with crizotinib.

 Despite longer median treatment duration, the safety profile of Alecensa remains favourable and consistent with previous data, with no new safety signals identified.

The overall survival (OS) data, which are not yet mature, show a benefit in patients with CNS metastases at baseline (42% reduction in the risk of death versus crizotinib (95% CI: 0.34-1.00)), as well as in those without CNS metastases at baseline (24% reduction in the risk of death versus crizotinib (95% CI: 0.45-1.26)).

These data follow on from the final, mature progression-free survival data from the ALEX study, presented at the European Society for Medical Oncology (ESMO) congress in September 2019, which demonstrated a reduced risk of disease worsening or death by 57% (hazard ratio=0.43, 95% CI: 0.32–0.58) with Alecensa, versus crizotinib, in ALK-positive NSCLC.

The updated data confirm the superior efficacy and tolerability of Alecensa in comparison to crizotinib.

Approximately 85% of lung cancer cases are NSCLC and, of these people, about 5% are ALK-positive.

 ALK-positive NSCLC is caused by a gene fusion or rearrangement that overactivates the ALK protein, driving cancer cell growth and survival.

The disease often affects those who least expect it; 50% of patients are younger than 50 years and approximately 70% have never smoked.

ALEX study
ALEX (NCT02075840/B028984) is a randomised, multicentre, open-label, phase III study evaluating the efficacy and safety of Alecensa versus crizotinib in treatment-naïve patients with ALK-positive NSCLC whose tumours were characterised as ALK-positive by the VENTANA ALK (D5F3) CDx Assay, companion immunohistochemistry (IHC) test developed by Roche Tissue Diagnostics.

Patients were randomised (1:1) to receive either Alecensa or crizotinib.

The primary endpoint of the ALEX study was progression-free survival (PFS) as assessed by the investigator, and secondary endpoints included: Independent Review Committee (IRC)-assessed PFS, time to CNS progression, objective response rate (ORR), duration of response (DOR) and OS.

The multicentre study was conducted in 303 people across 161 sites in 31 countries. OS data continue to be considered immature.

Alecensa
Alecensa (RG7853/AF-802/RO5424802/CH5424802) is a highly selective, CNS active, oral medicine created at Chugai Kamakura Research Laboratories and is being developed for people with NSCLC whose tumours are identified as ALK-positive.

 ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.

It is almost always found in people with a specific type of NSCLC called adenocarcinoma.

Alecensa is now approved in 88 countries as an initial (first-line) treatment for ALK-positive, metastatic NSCLC, including in the US, Europe, Japan and China.”
https://www.roche.com/media/releases/med-cor-2020-05-29.htm

KEYTRUDA® plus LENVIMA® Combination Demonstrated Meaningful Tumor Response Rates in Unresectable Hepatocellular Carcinoma and Advanced Renal Cell Carcinoma

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KEYTRUDA® plus LENVIMA® Combination Demonstrated Meaningful Tumor Response Rates in Unresectable Hepatocellular Carcinoma and Advanced Renal Cell Carcinoma
May 28, 2020: “Merck is known as MSD outside the United States and Canada, and Eisai announced new data from analyses of two trials evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, an orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.

In the KEYNOTE-524/Study 116 and KEYNOTE-146/Study 111 trials, the KEYTRUDA plus LENVIMA combination demonstrated clinically meaningful objective response rates (ORR) in patients with unresectable hepatocellular carcinoma (HCC) with no prior systemic therapy and in patients with metastatic clear cell renal cell carcinoma (ccRCC) who progressed following immune checkpoint inhibitor therapy, respectively.

“The tumor response rates demonstrated with KEYTRUDA plus LENVIMA in these studies underscore the potential of this combination regimen in certain types of hepatocellular and renal cell carcinoma,” said Dr. Jonathan Cheng, Vice President, Oncology Clinical Research, Merck Research Laboratories.

“KEYTRUDA plus LENVIMA is an important pillar of our broad oncology research program, and we continue to advance the study of the combination across multiple types of cancers and stages of the disease.”

“As data from our combination trials continue to read out, our enthusiasm for and belief in the potential of KEYTRUDA plus LENVIMA are strengthened by the growing body of evidence observed in multiple advanced cancers,” said Dr. Takashi Owa, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai.

“Our ongoing clinical study efforts on this combination exemplify our commitment to following the science and exploring possible solutions for patients affected by difficult-to-treat cancers.”

More Related News: Merck’s KEYTRUDA® Superior to Standard of Care Chemotherapy in Patients with MSI-H Colorectal Cancer

KEYNOTE-524/Study 116 Trial Design and Data (Abstract #4519)

KEYNOTE-524/Study 116 (ClinicalTrials.gov, NCT03006926) is a Phase 1b, open-label, single-arm trial evaluating the KEYTRUDA plus LENVIMA combination in 100 patients with unresectable HCC with no prior systemic therapy.

Patients have treated with KEYTRUDA 200 mg intravenously every three weeks in combination with LENVIMA 8 or 12 mg (based on baseline body weight ˂60 kilograms or ≥60 kilograms, respectively) orally once daily.

The primary endpoints are ORR and duration of response (DOR) by modified Response Evaluation Criteria in Solid Tumors (mRECIST) and RECIST v1.1 per independent imaging review (IIR). Secondary endpoints include progression-free survival (PFS), time to progression (TTP) and overall survival (OS).

At data cutoff (Oct. 31, 2019) and a median duration of follow-up of 10.6 months (95% CI: 9.2-11.5), 37 patients were still on study treatment (KEYTRUDA plus LENVIMA: n=34; LENVIMA only: n=3), and the median duration of treatment exposure to the KEYTRUDA plus LENVIMA combination was 7.9 months (range: 0.2-31.1).

The final analysis of the study’s primary endpoints showed the KEYTRUDA plus LENVIMA combination demonstrated an ORR of 36% (n=36) (95% CI: 26.6-46.2), with a complete response rate of 1% (n=1) and a partial response rate of 35% (n=35), and a median DOR of 12.6 months (95% CI: 6.9-not estimable [NE]), using RECIST v1.1 criteria per IIR.

As assessed using mRECIST criteria per IIR, the KEYTRUDA plus LENVIMA combination demonstrated an ORR of 46% (n=46) (95% CI: 36.0-56.3), with a complete response rate of 11% (n=11) and a partial response rate of 35% (n=35), and a median DOR of 8.6 months (95% CI: 6.9-NE).

Treatment-related adverse events (TRAEs) led to discontinuation of KEYTRUDA and LENVIMA in 6% of patients, discontinuation of KEYTRUDA in 10% of patients, and discontinuation of LENVIMA in 14% of patients. Grade ≥3 TRAEs occurred in 67% of patients (Grade 3: 63%; Grade 4: 1%; Grade 5: 3%).

There was one Grade 4 TRAE (leukopenia/neutropenia), and there were three Grade 5 treatment-related deaths (acute respiratory failure/acute respiratory distress syndrome, intestinal perforation and abnormal hepatic function; n=1 for each).

The most common TRAEs of any grade (≥20%) were hypertension (36%), diarrhoea (35%), fatigue (30%), decreased appetite (28%), hypothyroidism (25%), palmar-plantar erythrodysesthesia syndrome (23%), decreased weight (22%), dysphonia (21%), increased aspartate aminotransferase (20%) and proteinuria (20%).

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells.

KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings.

The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.”
https://www.mrknewsroom.com/news-release/asco/keytruda-pembrolizumab-plus-lenvima-lenvatinib-combination-demonstrated-clinically

Merck’s KEYTRUDA® Superior to Standard of Care Chemotherapy in Patients with MSI-H Colorectal Cancer

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Merck’s KEYTRUDA® Superior to Standard of Care Chemotherapy in Patients with MSI-H Colorectal Cancer
May 28, 2020: “Merck known as MSD outside the United States and Canada, today announced the first presentation of results from KEYNOTE-177, a Phase 3 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, for the first-line treatment of patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer.

In this pivotal study, KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80; p=0.0002]) and showed a median progression-free survival (PFS) of 16.5 months compared with 8.2 months for patients treated with chemotherapy

(investigator’s choice of mFOLFOX6 or FOLFIRI, with or without bevacizumab or cetuximab), a current standard of care in this patient population.

As previously announced, the study will continue without changes to evaluate overall survival (OS), the other dual primary endpoint.

These results were selected for presentation on Sunday, May 31, 2020 in the plenary session of the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA4).

“For many years, the standard of care for the first-line treatment of patients with MSI-H colorectal cancer has been the combination of mFOLFOX6 plus bevacizumab.

More Related News: FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications

Merck’s Checkpoint Inhibitor Keytruda (pembrolizumab) Hits Another Mark in Breast Cancer

KEYTRUDA, Merck’s anti-PD-1 therapy Now Approved by the National Medical Products Administration in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in Combination with Chemotherapy

This is the first time a single-agent, anti-PD-1 therapy demonstrated a superior, statistically significant and clinically meaningful improvement in progression-free survival compared to chemotherapy for these patients,” said Dr Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

“There is an unmet need for new treatment options in the first-line setting that may provide sustained, long-term improvements in outcomes for patients with MSI-H colorectal cancer.

We are grateful to have the opportunity to present these practice-changing findings at the plenary session of this year’s ASCO.”

“KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40% versus standard of care chemotherapy, with fewer treatment-related adverse events observed, in patients with MSI-H metastatic colorectal cancer.

KEYTRUDA also demonstrated a long-term, durable response that lasted over two years for those who responded to treatment,” said Thierry Andre, MD, professor of medical oncology, Sorbonne University, and Head of the Medical Oncology Department in St. Antoine Hospital, Assistance Publique Hôpitaux de Paris.

“Data from KEYNOTE-177 show that KEYTRUDA monotherapy has the potential to become the new standard of care for first-line treatment of patients with MSI-H metastatic colorectal cancer.”

In May 2017, KEYTRUDA became the first cancer therapy approved by the U.S. Food and Drug Administration for use based on a biomarker, regardless of tumor type, in previously treated patients with MSI-H or dMMR solid tumors.

As announced, more than 80 abstracts in nearly 20 types of solid tumors and blood cancers will be presented from Merck’s broad oncology portfolio and investigational pipeline at ASCO. A compendium of presentations and posters of Merck-led studies will be posted by Merck on Friday, May 29 at 8 a.m. ET. Follow Merck on Twitter via @Merck and keep up to date with ASCO news and updates by using the hashtag #ASCO20.

KEYNOTE-177 Study Design and Additional Data (Abstract #LBA4)

KEYNOTE-177 is a randomized, open-label, Phase 3 trial evaluating KEYTRUDA monotherapy versus standard of care chemotherapy for the first-line treatment of patients with MSI-H or dMMR metastatic colorectal cancer (ClinicalTrials.gov, NCT02563002).

The dual primary endpoints are PFS and OS. The study enrolled 307 patients, who were randomized to receive either KEYTRUDA (200 mg intravenously on Day 1 of each three-week cycle for up to 35 cycles) or investigator’s choice of one of the following chemotherapy-based regimens: mFOLFOX6; mFOLFOX6 plus bevacizumab (5 mg/kg IV on Day 1 of each two-week cycle); mFOLFOX6 plus cetuximab (400 mg/m2 IV, then 250 mg/m2 weekly in each two-week cycle); FOLFIRI; FOLFIRI plus bevacizumab (5 mg/kg IV on Day 1 of each two-week cycle); or FOLFIRI plus cetuximab (400 mg/m2 IV, then 250 mg/m2 weekly in each two-week cycle).

In this study, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in PFS (HR=0.60 [95% CI, 0.45-0.80; p=0.0002]) and showed a median PFS of 16.5 months compared with 8.2 months for patients treated with chemotherapy. The two-year PFS rate was 48% with KEYTRUDA versus 19% with chemotherapy.

The ORR was 43.8% with KEYTRUDA versus 33.1% with chemotherapy, with a complete response observed in 11.1% and 3.9% of patients, respectively; partial responses were observed in 32.7% and 29.2% of patients, respectively.

The median duration of response was not reached with KEYTRUDA (range, 2.3+ to 41.4+) versus 10.6 months with chemotherapy (range, 2.8 to 37.5+). Additionally, 83% of patients had durable responses lasting at least two years with KEYTRUDA versus 35% with chemotherapy.

In the study, 59% of patients in the intent-to-treat population received subsequent anti-PD-1/PD-L1 therapy after discontinuing study treatment in the chemotherapy arm.

The safety profile of KEYTRUDA demonstrated a lower incidence of Grade ≥3 treatment-related adverse events (AEs) versus chemotherapy (22% versus 66%, respectively), and no new toxicities were observed.

Immune-mediated AEs and infusion reactions occurred in 31% of patients receiving KEYTRUDA and 13% of patients receiving chemotherapy.

The most commonly reported immune-mediated AEs were hypothyroidism (12%) and colitis (7%) with KEYTRUDA, and infusion reactions (8%) with chemotherapy.”

https://www.mrknewsroom.com/news-release/asco/mercks-keytruda-pembrolizumab-superior-standard-care-chemotherapy-patients-msi-h-c

Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020

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Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020

May 28, 2020: “The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • The FDA issued an Emergency Use Authorization for the Stryker Sustainability Solutions (SSS) VHP N95 Respirator Decontamination System (RDS).

    This product uses vapor hydrogen peroxide (VHP) to decontaminate compatible N95 respirators that are, or potentially are, contaminated with SARS-CoV-2 or other pathogenic microorganisms for multiple-user reuse by healthcare personnel to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.

    N95 respirators containing cellulose-based materials are incompatible with the SSS VHP N95 RDS.

    This system is operated by employees of Stryker Sustainability Solutions, whose facilities are designed to allow adequate space for receiving respirators for decontamination, visually inspecting respirators for gross contamination or damage, exposing respirators to VHP, and packaging or labeling them for return to the sender so as to minimize contamination and ensure orderly handling procedures. With respirators limited to a maximum of three decontaminations, each is permanently marked to indicate the number of decontamination cycles it has undergone.

  • Yesterday, the FDA further supported its effort to evaluate diagnostic tests of COVID-19 by providing a SARS-CoV-2 reference panel. This panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes.

    The FDA panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process or whose tests have been issued a EUA.

    The FDA will provide the reference panel to developers at the appropriate stage in the process.

    There is no need for these test developers to take additional action in order to receive the reference panel.

    For More News: https://lifepronow.com/blog/2020/05/28/coronavirus-covid-19-update-daily-roundup-may-27-2020/
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 113 tests under EUAs, which include 100 molecular tests, 12 antibody tests, and 1 antigen test.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-28-2020

FDA OK’s First Treatment for Bladder Dysfunction in children less than 2 years

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FDA OK’s First Treatment for Bladder Dysfunction in children less than 2 years
May 26, 2020: “The U.S. FDA granted approval to VESIcare LS (solifenacin succinate) oral suspension, a liquid taken by mouth, for the treatment of neurogenic detrusor overactivity (NDO), a form of bladder dysfunction related to neurological impairment, in children ages two years and older.

VESIcare (solifenacin succinate) tablets were initially approved in 2004 for the treatment of overactive bladder in adults 18 years and older.

“This is the first FDA-approved treatment for NDO patients as young as two years of age,” said Christine P. Nguyen, M.D., acting director, FDA’s Division of Urology, Obstetrics and Gynecology, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Center for Drug Evaluation and Research.

“In addition, prior to today’s approval, the current standard of care for many of these patients required up to three times a day dosing, and this treatment requires only once a day dosing.”
 
NDO is a dysfunction of the bladder that results from disease or injury in the nervous system.

NDO may be related to congenital conditions (often-inherited conditions beginning at or before birth), such as spina bifida (myelomeningocele), or other conditions such as spinal cord injury.

With NDO, there is overactivity of the bladder wall muscle, which normally relaxes to allow storage of urine.

The bladder wall muscle overactivity results in sporadic bladder muscle contraction, which increases pressure in the bladder and decreases the volume of urine the bladder can hold.

If NDO is not treated, increased pressure in the bladder can put the upper urinary tract at risk of harm, including possible permanent damage to the kidneys.

In addition, spontaneous bladder muscle contractions can lead to unexpected and frequent leakage of urine with symptoms of urinary urgency (immediate urge to urinate), frequency (urinating more often than normal) and incontinence (loss of bladder control).

The efficacy of VESIcare LS for this use was established in two clinical trials with a total of 95 pediatric NDO patients, ages two to 17 years old.

The studies were designed to measure (as a primary efficacy endpoint) the maximum amount of urine the bladder could hold after 24 weeks of treatment.

In the first study, 17 patients ages 2 to less than 5 years old were able to hold an average of 39 mL more urine than when the study began. In the second study, 49 patients ages five to 17 years were able to hold an average of 57 mL more urine than when the study began.

Reductions in spontaneous bladder contractions, bladder pressure and number of incontinence episodes were also observed in both studies.

The most common side effects of VESIcare LS are constipation, dry mouth and urinary tract infection.

Somnolence (sleepiness or drowsiness) has been reported with solifenacin succinate, the active ingredient in VESIcare LS.

Patients of age who are able to drive or operate heavy machinery should not do so until they know how VESIcare LS affects them. Health care professionals are advised not to exceed the recommended starting dose of VESIcare LS in patients also taking strong CYP3A4 inhibitors.

Severe allergic reactions, such as angioedema (swelling beneath the skin) and anaphylaxis, have been reported in patients treated with solifenacin succinate and may be life-threatening.

Patients should seek immediate attention if they experience swelling of the tongue or throat or difficulty breathing.

VESIcare LS is not to be used in patients with gastric retention (reduced emptying of the stomach), uncontrolled narrow angle glaucoma (fluid buildup in the eye which raises eye pressure) or hypersensitivity (allergic reaction) to VESIcare LS or any of its components.

VESIcare LS is also not recommended for use in patients with severe liver failure, clinically significant bladder outlet obstruction in the absence of clean intermittent catheterization, decreased gastrointestinal motility (slowed intestinal contractions), or at high risk of QT prolongation (an electrical disturbance where the heart muscle takes longer than normal to recharge between beats), including patients with a known history of QT prolongation and patients taking medications known to prolong the QT interval. 
 
The approval of VESIcare LS was granted to Astellas Pharma US, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”
https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-form-bladder-dysfunction-pediatric-patients-young-2-years-age

Coronavirus (COVID-19) Update: Daily Roundup May 27, 2020

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Coronavirus (COVID-19) Update: Daily Roundup May 27, 2020
May 27, 2020: The U.S. Food and Drug Administration continued to take action in the ongoing response effort to the COVID-19 pandemic:
  • The FDA issued a guidance entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency.”

    The guidance provides a mechanism for FDA-regulated establishments (human food facilities and farms) to voluntarily notify the agency of temporary closures and significant reductions in operations and to request assistance from FDA on issues that might affect the continuity of their operations during the pandemic.
  • The FDA issued a guidance document entitled “Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications” to provide answers to frequently asked questions.

    The agency is providing answers concerning certain aspects of sponsor requests for formal meetings with industry, user fee applications goals and timelines, and prioritization of drug and biological application reviews during the public health emergency.
  • The FDA and Federal Trade Commission (FTC) issued warning letters to four companies for promoting and participating in the sale of fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19.

    Consumers concerned about COVID-19 should consult with their health care provider.
    • The first company warned, CBD Gaze, participates in the Amazon Associates program.

      As an Amazon associate, the company earns commissions by promoting the sale of CBD products with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people.
    • The second company warned, Alternavita, participates in the Amazon Associates program.

      As an Amazon associate, the company earns commissions by promoting the sale of grapefruit seed extract, colostrum, and cod liver oil products with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people.
    • The third company warned, Musthavemom.com, participates in the Amazon Associates program.

      As an Amazon associate, the company earns commissions by promoting the sale of products including colloidal silver, vitamins, minerals, herb oils and a homeopathic drug product with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people.
    • The fourth company warned Careful Cents, LLC, participates in the Amazon Associates program. As an Amazon associate, the company earns commissions by promoting the sale of essential oil products with misleading claims that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people.
  • Today, a judge in the U.S. District Court for the Eastern District of Oklahoma entered a preliminary injunction against Xephyr LLC, doing business as N-Ergetics, and individual defendants Brad Brand, Derill J. Fussell and Linda Fussell.

    The injunction requires Xephyr and the associated individuals to, among other things, immediately stop distributing colloidal silver products.

    It was issued on the same basis as a temporary restraining order entered by the court on May 14, 2020.

    As noted then, defendants offered their colloidal silver products for sale to treat coronavirus, which includes COVID-19 and many other diseases, and, which FDA alleges violates the Federal Food, Drug, and Cosmetic Act (FD&C) because the products are unapproved new drugs and misbranded drugs.

    The preliminary injunction governs throughout the course of the legal proceeding, thereby disrupting the supply chain for defendants’ fraudulent colloidal silver products until the court rules on permanent relief.

    The complaint was filed by the U.S. Department of Justice at FDA’s request.

    The claims made in the complaint are allegations that, if the case were to proceed to trial, the government must prove to receive a permanent injunction.
  • The FDA issued a letter to health care providers to remind reprocessing staff in health care facilities to use the correct sterilization cycle associated with certain models of the Advanced Sterilization Products (ASP) STERRAD Sterilization Systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the COVID-19 pandemic.

    These sterilization systems help increase the availability of respirators by allowing decontaminated compatible respirators to be reused so health care workers on the front lines can be better protected when providing care to patients with COVID-19.
  • Yesterday, the FDA issued two guidance documents (one new guidance and one revised guidance) for the industry to help address potential shortages of face masks, surgical masks, respirators, and face shields for use during the COVID-19 public health emergency: Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised).

    These guidances help to address potential shortages by facilitating the safe reuse and conservation of surgical masks and respirators for medical purposes through the use of decontamination and bioburden reduction systems and providing recommendations of alternatives and updated options for when FDA-cleared or NIOSH-approved N95 respirators are not available.
  • Yesterday, the FDA issued an Emergency Use Authorization (EUA) for emergency use of the CLEWICU System of CLEW Medical Ltd for use by healthcare providers in the intensive care unit (ICU) as a diagnostic aid to assist with the early identification of adult patients who are likely to be diagnosed with respiratory failure or hemodynamic instability which are common complications associated with COVID-19.

    The CLEWICU system utilizes the full range of available patient data to provide continuous predictions based on data-driven algorithms and machine learning models.

    The CLEWICU system delivers workflow improvements and dynamic worklist prioritization, enabling healthcare providers to spend less time on administration and more time on patient treatment.

    In this way, CLEWICU may reduce the contact between ICU personnel and patients by providing the ICU clinician with the ability to view the patient risk status from a remote location.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 113 tests under EUAs, which include 100 molecular tests, 12 antibody tests, and 1 antigen test.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-may-27-2020

NICE u-turn backs Roche’s Tecentriq for small-cell lung cancer

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NICE u-turn backs Roche’s Tecentriq for small-cell lung cancer
May 28, 2020: “A new treatment option for patients with extensive-stage small-cell lung cancer has been approved by the National Institute for Health and Care Excellence (NICE).

In new draft guidance, atezolizumab (also called Tecentriq®▼ and made by Roche) with carboplatin and etoposide has been recommended as an option for untreated extensive-stage small-cell lung cancer (ES-SCLC).

Around 2400 people in England have ES-SCLC, of whom around 1200 people will be eligible for treatment with atezolizumab with carboplatin and etoposide.

The positive recommendation follows consultation on NICE’s previous draft guidance which did not recommend the treatment.

The company has since agreed on a new price for atezolizumab with NHS England and Improvement, which means that the treatment is now considered a cost-effective use of NHS resources.

The clinical trial evidence for the combination treatment was based on patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Clinical experts suggested that the effects of the treatment may be different for people with a score of 2 or higher, that is, a more severe illness, so atezolizumab with carboplatin and etoposide was recommended only for patients with an ECOG performance status of 0 or 1.

For More News; FDA’s OK for Roche’s Tecentriq for metastatic non-small cell lung cancer

Roche presents pivotal First Phase III cancer immunotherapy Tecentriq in combination with Avastin to show an improvement in liver cancer patients

Gemma Boni, Head of Lung Cancer, Roche Products Limited said: “Extensive-Stage Small Cell Lung Cancer is an aggressive and unforgiving disease and there has been a requirement to bring new treatment options to these patients.

This is the first advance in systemic treatment in decades and we are proud to have collaborated with the clinical community and NICE to ensure patients can benefit from this medicine.”

Meindert Boysen, Deputy Chief Executive Officer and Director of the Centre for Health Technology Evaluation at NICE, said: “We are pleased to be able to recommend this new treatment that could extend the life of patients with this type of lung cancer.

“I know how important this news will be for patients suffering with this condition, for which there are currently few treatment options.

Atezolizumab with carboplatin and etoposide may offer valuable time for patients to spend with their loved ones.”

ES-SCLC is a form of lung cancer accounting for 1 in 8 lung cancer cases in the UK.

It is an aggressive disease that progresses rapidly, with a significant negative impact on the quality of life of patients.

Clinical trial evidence suggests that atezolizumab with carboplatin and etoposide increases the time before the disease worsens by around 1 month compared with standard chemotherapy (5.2 months versus 4.3 months respectively).

It also suggests that atezolizumab plus carboplatin and etoposide increases overall survival compared with standard chemotherapy. However, the long-term benefit on overall survival was uncertain.

NICE expects to publish its final guidance on atezolizumab for ES-SCLC in June 2020.”

https://pharmafield.co.uk/pharma_news/new-treatment-option-for-extensive-stage-small-cell-lung-cancer-approved/

Roche’s OCREVUS shorter 2-hour infusion time approved

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Roche’s OCREVUS shorter 2-hour infusion time approved
May 28, 2020: “Roche announced European Medicines Agency (EMA) approval of a new, shorter two-hour OCREVUS® (ocrelizumab) infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis (MS).

The approval is based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

“The approval of a shorter, two-hour infusion time for OCREVUS in Europe, dosed twice yearly, will further improve the treatment experience for patients while also increasing capacity in healthcare systems,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “With more than 160,000 people treated with OCREVUS globally, a shorter infusion may assist both patients and healthcare providers to reach the ultimate goal of slowing disease progression in MS.’’

The approval is based on data from the randomised, double-blind ENSEMBLE PLUS study, which showed comparable frequency and severity of infusion-related reactions (IRRs) for a two-hour OCREVUS infusion time vs. the conventional 3.5-hour time in patients with relapsing-remitting MS (RRMS) (289 patients shorter infusion; 291 conventional infusion). The first dose was administered per the approved dosing schedule (two 300 mg intravenous (IV) infusions separated by two weeks) and the second or later doses (600 mg IV infusion) were administered over a shorter, two-hour time.

The primary endpoint of this study was the proportion of patients with IRRs following the first randomised 600 mg infusion (frequency/severity assessed during and 24-hours post infusion).

The frequency of IRRs was comparable between those who received the two-hour infusion (24.6%) and those who received the 3.5-hour infusion (23.1%).

The majority of IRRs were mild or moderate, and more than 98% resolved in both groups without complication.

No IRRs were life-threatening, serious or fatal. No patients discontinued the study due to an IRR and no new safety signals were detected.

The U.S. Food and Drug Administration accepted a supplemental Biologics License Application for a two-hour OCREVUS infusion time and is expected to make a decision by 14 December 2020.

With rapidly growing real-world experience and more than 160,000 patients treated globally, OCREVUS has twice-yearly (six-monthly) dosing and is the first and only therapy approved for RMS (including relapsing-remitting MS (RRMS) and active, or relapsing, secondary progressive MS, in addition to clinically isolated syndrome in the U.S.) and primary progressive MS (PPMS).

OCREVUS is approved in 90 countries across North America, South America, the Middle East, Eastern Europe, as well as in Australia, Switzerland and the European Union.

OCREVUS® (ocrelizumab)
OCREVUS is the first and only therapy approved for both RMS (including RRMS and active, or relapsing, SPMS, in addition to CIS in the U.S.) and PPMS.

OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage.

This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved.

OCREVUS is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions.”
https://www.roche.com/media/releases/med-cor-2020-05-28b.htm

Roche initiates phase III clinical trial of Actemra/RoActemra plus remdesivir

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Roche initiates phase III clinical trial of Actemra/RoActemra plus remdesivir
May 28, 2020: “Roche announced the initiation of a global phase III, randomised, double-blind, multicentre study (REMDACTA) to evaluate the safety and efficacy of Actemra/RoActemra plus the investigational antiviral remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia, in collaboration with Gilead Sciences, Inc. 

“As more information about COVID-19 pneumonia becomes available in these unprecedented times, it is more important than ever to work together to fight this disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.

“Based on our current understanding, we believe that combining an antiviral with an immune modulator could potentially be an effective approach to treating patients with severe disease.

We’re pleased to partner with Gilead to determine whether combining these medicines could potentially help more patients during this pandemic.”

The study is expected to begin enrolling in June with a target of approximately 450 patients globally, including the US, Canada and Europe.

In addition to REMDACTA, Roche is close to completing enrolment of the global randomised, double-blind, placebo-controlled phase III clinical trial (COVACTA, NCT04320615) to evaluate the safety and efficacy of intravenous Actemra/RoActemra plus standard of care (SOC), versus placebo plus SOC in hospitalised adult patients with severe COVID-19 pneumonia.

The first patient was randomised on April 3. In total, approximately 450 patients will be enrolled in COVACTA.

This increase from the original target of 330 patients will allow for even more robust data, while minimally extending the recruitment period.

Roche is committed to sharing data from the COVACTA study as soon as possible this summer. In addition, the protocol for COVACTA allows the inclusion of patients who are being treated with antivirals, including investigational antivirals.

Data from the REMDACTA trial are designed to supplement the COVACTA study.

The COVACTA study is conducted in collaboration with the US FDA and the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR).

Roche is also a participant in the Accelerated COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, led by the National Institutes of Health (NIH) and the Foundation of the NIH.

Remdesivir has been issued an Emergency Use Authorisation by the US Food & Drug Administration (FDA) for the treatment of hospitalised patients with severe COVID-19.

Remdesivir is an investigational antiviral drug that is being studied in multiple ongoing international clinical trials, and the safety and efficacy of remdesivir for the treatment of COVID-19 are not yet established.

Remdesivir has not been approved by the US FDA for any use. For information about the authorized use of remdesivir and mandatory requirements of the Emergency Use Authorisation in the US, please review the Fact Sheet for Healthcare Providers and FDA Letter of Authorisation available at www.gilead.com/remdesivir.

REMDACTA Clinical trial
REMDACTA is a two-armed global phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of Actemra/RoActemra plus remdesivir, versus placebo plus remdesivir in hospitalised patients with severe COVID-19 pneumonia receiving standard of care (SOC).

The primary and secondary endpoints include clinical status, mortality, mechanical ventilation, and intensive care variables. Patients will be followed for 60 days post-randomisation.

COVACTA Clinical Trial
COVACTA is a double-blind, placebo-controlled phase III study (COVACTA, NCT04320615) evaluating the safety and efficacy of intravenous Actemra/RoActemra added to standard of care in approximately 450 adult patients hospitalised with severe COVID-19 pneumonia compared to placebo plus standard of care.

The primary endpoint is clinical status assessed using a 7-Category Ordinal Scale at day 28.

The ordinal scale ranges from one (discharged from the hospital) to seven (death) and covers different hospital locations such as non-intensive care unit (non-ICU) or ICU, and ventilation/treatment requirements, including not requiring supplemental oxygen or requiring extracorporeal membrane oxygenation (ECMO) or mechanical ventilation and additional organ support.

Key secondary endpoints include mortality, mechanical ventilation, clinical status at day 14, time to clinical improvement, and time to discharge.

Actemra/RoActemra
Actemra/RoActemra was the first approved anti-IL-6 receptor biologic available in both intravenous (IV) and subcutaneous (SC) formulations for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA).

Actemra/RoActemra can be used alone or with methotrexate (MTX) in adult RA patients who are intolerant to, or have failed to respond to, other disease-modifying anti-rheumatic drugs (DMARDs).

In Europe, RoActemra IV and SC are also approved for use in adult patients with severe, active and progressive RA who previously have not been treated with MTX.

Actemra/RoActemra IV and SC are approved globally for polyarticular juvenile idiopathic arthritis (pJIA) and in the US and Europe for systemic juvenile idiopathic arthritis (sJIA) in children two years of age and older.

Actemra/RoActemra SC injection is also the first approved therapy for the treatment of giant cell arteritis (GCA) in more than 40 countries, including the US and Europe.

In the US and Europe, Actemra/RoActemra IV injection is approved for the treatment of chimeric antigen receptor (CAR) T-cell-induced severe or life-threatening cytokine release syndrome (CRS) in people two years of age and older.

Actemra/RoActemra was the first approved treatment for CRS in this setting. A prefilled autoinjector ACTPen has been approved in the US and Europe.

In Japan, Actemra is also approved for the treatment of Castleman’s Disease, adult Still’s disease and Takayasu Arteritis. Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since April 2005.

Actemra/RoActemra is approved in more than 110 countries worldwide.”
https://www.roche.com/media/releases/med-cor-2020-05-28.htm

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