CLINSQUARE: CLINICAL RESEARCH COURSES
Friday, June 6, 2025
CLINSQUARE: Clinical Rsearch Courses by LIFEPRONOW
Home Blog Page 46

FDA Authorizes Software that Can Help Identify Prostate Cancer

admin
-
0
FDA Authorizes Software that Can Help Identify Prostate Cancer

September 21, 2021: “The U.S. Food and Drug Administration authorized marketing of software to assist medical professionals who examine body tissues (pathologists) in the detection of areas that are suspicious for cancer as an adjunct (supplement) to the review of digitally-scanned slide images from prostate biopsies (tissue removed from the body).

The software, called Paige Prostate, is the first artificial intelligence (AI)-based software designed to identify an area of interest on the prostate biopsy image with the highest likelihood of harboring cancer so it can be reviewed further by the pathologist if the area of concern has not been identified on initial review.

“Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day.

Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the appropriate treatment,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

“The authorization of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives.”

Cancer that starts in the prostate is called prostate cancer. According to the Centers for Disease Control and Prevention, aside from non-melanoma skin cancer, prostate cancer is the most common cancer among men in the United States. It is also one of the leading causes of cancer death among men.

Paige Prostate is compatible for use with slide images that have been digitized using a scanner. The digitized slide image can then be visualized using a slide image viewer.

The FDA evaluated data from a clinical study where 16 pathologists examined 527 slide images of prostate biopsies (171 cancer and 356 benign) that were digitized using a scanner.

For each slide image, each pathologist completed two assessments, one without Paige Prostate’s assistance (unassisted read) and one with Paige Prostate’s assistance (assisted read).

While the clinical study did not evaluate the impact on final patient diagnosis, which is typically based on multiple biopsies, the study found that Paige Prostate improved detection of cancer on individual slide images by 7.3% on average when compared to pathologists’ unassisted reads for whole slide images of individual biopsies, with no impact on the read of benign slide images.

Potential risks include false negative and false positive results, which is mitigated by the device’s use as an adjunct (e.g., the device assists pathologists reviewing slide images) and by the professional evaluation by a qualified pathologist who takes into account patient history among other relevant clinical information, and who may perform additional laboratory studies on the samples prior to rendering a final diagnosis.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing.

When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type.

This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Paige Prostate software to Paige.AI.”

https://www.fda.gov/news-events/press-announcements/fda-authorizes-software-can-help-identify-prostate-cancer

FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals

admin
-
0
FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals

September 22, 2021: “The U.S FDA issued for public comment two draft guidance documents that, if finalized, will help manufacturers of animal cells, tissues, and cell- and tissue-based products (ACTPs) understand current good manufacturing practice requirements (CGMPs) for new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

CGMPs help prevent contamination and help ensure ACTP quality. If finalized, the recommendations are intended to support the development of promising and innovative products that can benefit animal health. 

“ACTPs have the potential to make significant changes in how we treat diseases and may provide novel therapies for unmet therapeutic needs of animals. We want to support manufacturers in the safe production of these promising products,” said Dr. Janet Woodcock, Acting Commissioner of the FDA.

“It is important to note that the FDA is not imposing any new requirements on the manufacturers of ACTPs with these new draft guidance documents.

These draft guidance documents, if finalized, are intended to assist manufacturers by providing product-specific recommendations that will help developers of these products meet existing FDA manufacturing requirements.

Our goal is to help manufacturers be successful in their efforts to develop innovative products that can benefit animal health.”

In the draft guidance, ACTPs are defined as products that contain, consist of, or are derived from cells or tissues that are intended for implantation, transplantation, infusion or transfer into an animal recipient.

Furthermore, ACTPs refer to products that meet the definition of a new animal drug. In the draft guidance, ACTPs include both cell-based products and animal stem cell-based products.

ACTPs are most commonly investigated for regenerative medicine applications because they have the potential to repair diseased or damaged tissues in animals through regeneration and healing.

Currently, these products are most commonly investigated and used in companion animals including dogs, cats, and horses; however, ACTPs may be also be developed for use in other species. 

All new animal drugs are required to be manufactured in accordance with CGMPs to ensure that such drugs meet the requirements of the FD&C Act for safety, and to have the identity, strength, quality, and purity characteristics which they purport to or are represented to possess.

Because the manufacture of ACTPs present unique considerations for complying with CGMPs, the FDA is issuing two draft guidance documents for industry. 

The first draft guidance, #253, “Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products” provides manufacturers of ACTPs with recommendations for meeting requirements for CGMPs.

It addresses the methods, facilities and controls used for manufacturing ACTPs, including steps in recovery, processing, storage, labeling, packaging and distribution. The draft guidance also addresses methods for preventing contamination and ensuring quality of the ACTP during manufacturing.

The second draft guidance #254, “Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products”, if finalized, will assist sponsors, firms or establishments that participate in the manufacture of ACTPs or perform any aspect of the ACTP donor eligibility determination.

Selecting appropriate donors is critical to product quality and preventing the transmission of disease. 

The concepts and principles in these draft guidance documents are consistent with the FDA’s Center for Biologics Evaluation and Research’s (CBER’s) regulations (21 CFR 1271 subparts C and D) and associated guidance documents for human cells, tissues, and cellular and tissue-based products.

“The FDA is seeking to improve transparency by engaging early in the development process and informing industry of our draft recommendations now, while the industry is still taking shape, as we are receiving applications seeking approval of ACTPs for use in animals,” said Dr. Steven Solomon, director of the FDA’s Center for Veterinary Medicine.

“As part of our commitment to fostering the development of innovative products in the most streamlined and efficient manner possible, we’re encouraging the ACTP industry to take advantage of our Veterinary Innovation Program, which is designed to assist product developers generate the appropriate data needed to support a new animal drug application.” 

The FDA recommends sponsors and manufacturers of ACTPs contact the FDA early and often in the product development process to discuss considerations specific to the manufacture and approval of new animal drug products.

The FDA has developed a process for these interactions through participation in its Veterinary Innovation Program, a program available to most ACTPs and aimed at providing greater certainty in the regulatory process, encouraging research and development, and supporting an efficient and predictable pathway to approval for these innovative products.

The FDA is accepting public comments on both draft guidance documents until November 22, 2021 so that we may consider comments before potentially issuing final guidance documents; however, comments on guidance documents are welcome at any time.

Later this year, the FDA will also host a webinar to discuss the draft guidance documents for all interested stakeholders.”

https://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-donor-eligibility-and-manufacturing-cellular-therapies-animals

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

admin
-
0
FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

September 22, 2021: “The U.S. FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:individuals 65 years of age and older;

individuals 18 through 64 years of age at high risk of severe COVID-19; and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

Today’s authorization applies only to the Pfizer-BioNTech COVID-19 Vaccine. 

“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic.

After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” said Acting FDA Commissioner Janet Woodcock, M.D.

“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day.

As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”

The Process for Assessing the Available Data

Comirnaty (COVID-19 Vaccine, mRNA), was approved by the FDA on Aug. 23, for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. On Aug. 25, 2021, the FDA received a supplement from Pfizer Inc. to their biologics license application for Comirnaty seeking approval of a single booster dose to be administered approximately six months after completion of the primary vaccination series for individuals 16 years of age and older.

As part of the FDA’s commitment to transparency, the agency convened a public meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Sept. 17 to solicit input from independent scientific and public health experts on the data submitted in the application. During the meeting, the vaccine manufacturer presented information and data in support of its application.

The FDA also presented its analysis of clinical trial data submitted by the vaccine manufacturer. Additionally, the public was also given an opportunity to provide comment; and FDA invited international and U.S. agencies and external groups, including representatives from the Israeli Ministry of Health, the University of Bristol, U.K. and the Centers for Disease Control and Prevention, to present recent data on the use of vaccine boosters, epidemiology of COVID-19, and real-world evidence on vaccine effectiveness.

The FDA considered the data that the vaccine manufacturer submitted, information presented at the VRBPAC meeting, and the committee’s discussion, and has determined that based on the totality of the available scientific evidence, a booster dose of Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19 and that the known and potential benefits of a booster dose outweigh the known and potential risks in the populations that the FDA is authorizing for use.

The booster dose is authorized for administration to these individuals at least six months following completion of their primary series and may be given at any point after that time.  

It’s important to note that the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine is the same formulation as the FDA-approved Comirnaty and the vaccines may be used interchangeably. 

“We’re grateful for the advice of the doctors, scientists, and leading vaccine experts on our advisory committee and the important role they have played in ensuring transparent discussions about COVID-19 vaccines.

We appreciate the robust discussion, including the vote regarding individuals over 65 years of age and individuals at high risk for severe disease, as well as the committee’s views regarding the use of a booster dose for those with institutional or occupational exposure to SARS-CoV-2,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research.

“The FDA considered the committee’s input and conducted its own thorough review of the submitted data to reach today’s decision. We will continue to analyze data submitted to the FDA pertaining to the use of booster doses of COVID-19 vaccines and we will make further decisions as appropriate based on the data.” 

Data Supporting Authorization for Emergency Use

To support the authorization for emergency use of a single booster dose, the FDA analyzed safety and immune response data from a subset of participants from the original clinical trial of the Pfizer-BioNTech COVID-19 Vaccine. In addition, consideration was given to real-world data on the vaccine’s efficacy over a sustained period of time provided by both U.S. and international sources, including the CDC, the UK and Israel.

The immune responses of approximately 200 participants 18 through 55 years of age who received a single booster dose approximately six months after their second dose were assessed.

The antibody response against SARS-CoV-2 virus one month after a booster dose of the vaccine compared to the response one month after the two-dose primary series in the same individuals demonstrated a booster response. 

Additional analysis conducted by the manufacturer, as requested by the FDA, compared the rates of COVID-19 accrued during the current Delta variant surge among original clinical trial participants who completed the primary two-dose vaccination series early in the clinical trial to those who completed a two-dose series later in the study.

The analysis submitted by the company showed that during the study period of July and August 2021, the incidence of COVID-19 was higher among the participants who completed their primary vaccine series earlier, compared to participants who completed it later.

The FDA determined that the rate of breakthrough COVID-19 reported during this time period translates to a modest decrease in the efficacy of the vaccine among those vaccinated earlier.

Safety was evaluated in 306 participants 18 through 55 years of age and 12 participants 65 years of age and older who were followed for an average of over two months.

The most commonly reported side effects by the clinical trial participants who received the booster dose of the vaccine were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills.

Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA for individuals 16 years of age and older.

The authorization was expanded on May 10, 2021 to include those 12 through 15 years of age, and again on Aug. 12, 2021 to include the use of a third dose of a three-dose primary series in certain immunocompromised individuals 12 years of age and older.

EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

The amendment to the EUA to include a single booster dose was granted to Pfizer Inc.”
 

https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations

AZ to discover and develop self-amplifying RNA therapeutics with VaxEquity

admin
-
0
AZ to discover and develop self-amplifying RNA therapeutics with VaxEquity

September 23, 2021: “AstraZeneca has reached an agreement to collaborate with VaxEquity for the discovery, development and commercialisastion of the proprietary self-amplifying RNA (saRNA) therapeutics platform developed at Imperial College London.

The strategic, long-term research collaboration aims to optimise and validate VaxEquity’s saRNA platform and apply it to advance novel therapeutic programmes. AstraZeneca will support VaxEquity with research and development funding and should AstraZeneca advance any of the research programmes into its pipeline, VaxEquity could receive development, approval and sales based milestones totalling up to $195 million and royalties in the mid-single digits per programme.

AstraZeneca has the option to collaborate with VaxEquity on up to 26 drug targets and will also make an investment in VaxEquity to further the development of the saRNA platform.

VaxEquity was founded by Imperial College London and Morningside in 2020 based on the innovative saRNA technology developed by Professor Robin Shattock and his colleagues at Imperial College London, UK.

saRNA is a new platform for the development of medicines and vaccines which uses similar technology to mRNA but with the added ability to self-amplify, thereby expressing proteins for longer, resulting in higher protein levels per dose level.

This has the potential to allow saRNAs to be delivered at lower concentrations than conventional mRNA therapeutics, leading to less frequent or lower dosing, lower costs and a much broader range of potential applications.

The saRNA platform aims to underpin the next generation of RNA-delivered medicines enabling not only vaccines but also broad range of therapeutic applications.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said “This collaboration with VaxEquity adds a promising new platform to our drug discovery toolbox. We believe self-amplifying RNA, once optimised, will allow us to target novel pathways not amenable to traditional drug discovery across our therapy areas of interest.”

Michael Watson, Executive Chairman of VaxEquity, said, “We are delighted to collaborate with AstraZeneca given its strong track record in innovation and welcome them as a new investor.

We are also grateful for the ongoing support of our existing investor, Morningside Group.

With our self-amplifying RNA platform, we aim to underpin the next generation of RNA-delivered medicines enabling not only vaccines but also broad range of therapeutics applications.”

Professor Alice Gast, President of Imperial College London, said: “I am deeply proud of my colleagues’ work in pioneering self-amplifying RNA technology.

This collaboration will help realise our ambition of building a lasting legacy from the great scientific advances Imperial made in this pandemic.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/astrazeneca-to-discover-and-develop-self-amplifying-rna-therapeutics-in-new-collaboration-with-vaxequity.html

Novartis acquires Arctos Medical, expanding optogenetics portfolio to bring gene therapies for vision loss

admin
-
0
Novartis acquires Arctos Medical, expanding optogenetics portfolio to bring gene therapies for vision loss

September 21, 2021: “Novartis announced that it has acquired Arctos Medical, adding a pre-clinical optogenetics-based AAV gene therapy program and Arctos’ proprietary technology to its ophthalmology portfolio.

The acquisition underscores the Novartis commitment to finding treatments for patients with vision loss and the potential of optogenetics as the basis of successful therapeutics.

“Optogenetics is emerging as a promising therapeutic approach that might restore sight to patients who are legally blind,” said Jay Bradner, President of the Novartis Institutes for BioMedical Research. “The Arctos technology builds on our conviction that optogenetic gene therapies may meaningfully help patients battling devastating eye diseases.”

Arctos developed its technology as a potential method for treating inherited retinal dystrophies (IRDs) and other diseases that involve photoreceptor loss, such as age-related macular degeneration (AMD).

Existing gene therapy treatments aim to correct a specific gene, so only a small subset of patients can benefit.

The Arctos technology is not limited to a specific gene, and thus can potentially address many forms of IRDs regardless of the underlying mutation.

Arctos’ proprietary, light-sensitive optogene is delivered to specific retinal cells using gene therapy, thus turning the targeted cells into replacement photoreceptor-like cells.

If successful, a therapeutic based on such a technology could be used to treat any disease that causes blindness due to photoreceptor death.

“We’ve watched this technology develop and mature into a therapeutic program that complements our existing portfolio and gives us new optogenetics technology to wield in our efforts to bring desperately needed therapeutic options to patients for these blinding diseases,” said Cynthia Grosskreutz, Global Head of Ophthalmology at the Novartis Institutes for BioMedical Research.

IRDs, which impact more than 2 million people globally and often result in complete blindness, can be caused by mutations in over 100 different genes.

AMD is the leading cause of visual disability, affecting an estimated 170 million people globally.2 There are no curative therapies currently available for AMD.

The Arctos technology was based on discoveries by its scientific co-founders Drs. Sonja Kleinlogel and Michiel van Wyk of University of Bern, Switzerland.

Arctos was originally incubated by +ND Capital and was later supported by Novartis Venture Fund through a Series A financing round led by +ND Capital.”

https://www.novartis.com/news/media-releases/novartis-acquires-arctos-medical-expanding-optogenetics-portfolio-bring-gene-therapies-patients-severe-vision-loss

AstraZeneca to invest $360m in advanced manufacturing facility in Ireland

admin
-
0
AstraZeneca to invest $360m in advanced manufacturing facility in Ireland

September 21, 2021: “AstraZeneca is planning on establishing a next-generation active pharmaceutical ingredient (API) manufacturing facility for small molecules near Dublin, Ireland to ensure the Company’s global supply network is fit for future growth.

The new plant will allow for late-stage development and early commercial supply, adopting state of the art process technology and digital innovation that is designed to meet the needs of the Company’s new medicines pipeline with speed and agility. 

The $360m planned investment at the Alexion Campus in College Park, Dublin, is expected to create about 100 highly skilled direct jobs, including scientists and engineers, and further indirect jobs.

The project, which will provide an important boost to the local economy and to the country’s life-sciences sector, was developed with the support and collaboration of Ireland’s investment agency, IDA Ireland.

Micheál Martin, Taoiseach, said: “I warmly welcome today’s announcement from AstraZeneca that it is to establish its first ever manufacturing facility in Ireland.

This $360 million investment represents a significant commitment to Ireland and will see 100 jobs being created. In choosing Ireland as the location for its new next-generation active pharmaceutical ingredient manufacturing facility, AstraZeneca joins the very strong and successful network of global life sciences companies we have in Ireland.

I wish them every success with their operations here.”

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: “This is a tremendously proud moment for us all at AstraZeneca and I am delighted that we are bringing this very significant investment to Dublin which, with the support of the IDA, will create highly skilled jobs, nurture the country’s dynamic life sciences sector and allow for the development of high value-added medicines.”

Pam Cheng, Executive Vice President, Global Operations and IT, said: “The future manufacturing of APIs for our medicines includes compounds with highly complex synthesis, requiring next generation technologies and capabilities that can respond quickly and nimbly to rapidly-changing clinical and commercial needs. 

This significant investment will ensure the AstraZeneca supply network is fit for the future.”

The investment programme is expected to significantly reduce commercialisation lead times, costs and introduce more sustainable manufacturing processes, contributing to the Company’s Ambition Zero Carbon programme.

The industry-leading, future proof design of the plant will permit the addition of capability to manufacture a wide range of medicines, including new modalities such as antibody drug conjugates and oligonucleotides.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/astrazeneca-360m-irish-manufacturing-investment.html

FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions

admin
-
0
FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions

September 17, 2021: “The U.S. Food and Drug Administration approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular degeneration (nAMD), a leading cause of vision loss and blindness for Americans aged 65 years and older.

Byooviz is also approved to treat macular edema (fluid build-up) following retinal vein occlusion (blockage of veins in the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness).

“Today’s approval provides another treatment option for millions of people whose vision is impaired and is another step forward in our commitment to provide access to safe, effective and high-quality biological products,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research.

“Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs.”

Neovascular (wet) age-related macular degeneration destroys the sharp, central vision needed to see clearly and can affect daily activities like reading, driving and watching television.

There are two types of AMD—dry and wet. While dry AMD is more common, wet AMD leads to vision loss at a faster rate. Both macular edema and myopic choroidal neovascularization can also lead to visual impairment.

Biological products are generally derived from a living organism and can come from many sources, including animals and microorganisms, such as bacteria or yeast.

A biosimilar is a biological product that is approved based on data showing that it is highly similar to a biological product already approved by the FDA (reference product) and has no clinically meaningful differences in terms of safety, purity and potency (i.e., safety and effectiveness) from the reference product, in addition to meeting other criteria specified by law.

Patients can expect the same safety and effectiveness from the biosimilar over the course of treatment as from the reference product.

The FDA’s approval of Byooviz was based on a review of evidence that included extensive structural and functional characterization, comparative clinical efficacy and safety evaluations, including potential immunogenicity (type of immune response) that demonstrated Byooviz is biosimilar to Lucentis.

To date, the FDA has approved 31 biosimilars, including one interchangeable biosimilar, for the treatment of a variety of health conditions.

Byooviz is administered by intravitreal injection (delivered into the vitreous humor of the eye) once a month.

Administration of Byooviz may cause serious side effects, including: endophthalmitis (infection inside the eye) and retinal detachments; increases in intraocular (inside the eye) pressure; and thromboembolic (obstruction of a blood vessel by a blood clot) events.

The most common side effects of Byooviz include conjunctival hemorrhage (broken blood vessel), eye pain, vitreous floaters (black spots that drift across the eye) and increased intraocular fluid pressure.

The FDA granted approval of Byooviz to Samsung Bioepis.”

https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-treat-macular-degeneration-disease-and-other-eye-conditions

ESMO data show Libtayo® and chemotherapy first-line treatment combination sfor NSCLC

admin
-
0
ESMO data show Libtayo® and chemotherapy first-line treatment combination sfor NSCLC

September 19, 2021: “Positive Phase 3 results for Sanofi and Regeneron Pharmaceuticals, Inc.’s Libtayo® (cemiplimab) combination treatment were presented during a late-breaking session at the European Society for Medical Oncology Virtual Congress 2021.

The trial, which met its primary overall survival (OS) endpoint and all key secondary endpoints, assessed the investigational use of PD-1 inhibitor Libtayo in combination with a physician’s choice of platinum-doublet chemotherapy (Libtayo combination) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) irrespective of histology and across all PD-L1 expression levels, compared to chemotherapy alone.

These results were also achieved in a patient population with varied baseline characteristics and will form the basis of regulatory submissions, including in the U.S. and European Union (EU).

“Libtayo added to chemotherapy significantly improved patient outcomes, extending median overall survival to 22 months and median progression-free survival to 8 months,” said Miranda Gogishvili, M.D., an oncologist at the High Technology Medical Center University Clinic, in Tbilisi, Georgia and a trial investigator. 

“Exploratory analyses showed that survival improvements were seen across squamous and non-squamous histologies and in patients with reduced daily functioning, with 43% of patients having squamous disease and 84% having an ECOG 1 performance status.

Furthermore, in another exploratory analysis, the Libtayo combination helped delay deterioration in patient-reported quality of life and pain symptoms.”

In the overall population, patients treated with the Libtayo combination (n=312) experienced significant improvements compared to those receiving chemotherapy alone (n=154), including a:

  • 22-month median OS compared to 13 months for chemotherapy, representing a 29% relative reduction in the risk of death (hazard ratio HR: 0.71; 95% confidence interval CI: 0.53 to 0.93; p=0.014). The 12-month probability of survival was 66% for the Libtayo combination and 56% for chemotherapy.
  • 8-month median progression-free survival (PFS) compared to 5 months for chemotherapy, representing a 46% relative reduction in the risk of disease progression (HR: 0.56; 95% CI: 0.44 to 0.70; p<0.0001). The 12-month probability of PFS was 38% for the Libtayo combination and 16% for chemotherapy.
  • 43% objective response rate (ORR) compared to 23% for chemotherapy.
  • 16-month median duration of response (DOR) compared to 7 months for chemotherapy.

Favorable patient-reported outcomes were also observed. Specifically, the Libtayo combination delayed deterioration in pain symptoms (HR: 0.39; 95% CI: 0.26 to 0.60; nominal p<0.0001) and showed a trend towards delayed deterioration in global health status/quality of life (HR: 0.78; 95% CI: 0.51 to 1.19; nominal p=0.248), compared to chemotherapy. The Libtayo combination also improved pain symptoms, compared to chemotherapy (-4.98 difference in baseline changes between treatment groups; 95% CI: -8.36 to -1.60; nominal p=0.004).

No new Libtayo safety signals were identified. The median duration of exposure was 38 weeks for the Libtayo combination (n=312) and 21 weeks for chemotherapy (n=153). Adverse events (AEs) of any grade occurred in 96% of patients receiving the Libtayo combination and 94% of patients receiving chemotherapy alone, with 19% and 0% being immune-mediated, respectively.

For the Libtayo combination and chemotherapy groups, the most common AEs were anemia (44%, 40%), alopecia (37%, 43%) and nausea (25%, 16%); grade ≥3 AEs occurring in ≥5% of patients were anemia (10%, 7%) and neutropenia (both 6%).

Treatment discontinuation due to AEs occurred in 5% of patients receiving the Libtayo combination and 3% receiving chemotherapy.

“These data add to the growing body of evidence supporting the use of Libtayo in patients with advanced non-small cell lung cancer,” said Peter C. Adamson, M.D., Global Development Head, Oncology and Pediatric Innovation at Sanofi. 

“With additional trials underway investigating Libtayo as the backbone in combinations with conventional and novel therapeutic approaches, we are encouraged by the potential to further improve outcomes for patients with difficult-to-treat cancers.”

Lung cancer is the leading cause of cancer death worldwide.

In 2020, an estimated 2.2 million and 225,000 new cases were diagnosed globally and in the U.S., respectively. Approximately 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages. While PD-1 inhibitor monotherapy has primarily advanced the treatment of NSCLC with ≥50% PD-L1 expression, approximately 70% of all NSCLC cases will have <50% PD-L1 expression, making it the most common treatment setting.

“This Phase 3 trial was stopped early because Libtayo significantly improved overall survival compared to chemotherapy, a milestone also achieved by our Phase 3 trial for Libtayo monotherapy as a first-line treatment for advanced non-small cell lung cancer with high PD-L1 expression,” said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. 

“Both trials were designed to reflect everyday clinical practice by allowing for the enrollment of patients with difficult-to-treat disease characteristics.

And this is the second Libtayo trial to demonstrate significant improvement in its primary and key secondary endpoints for these patient populations, compared to chemotherapy.”

The use of Libtayo in combination with chemotherapy for advanced NSCLC is investigational, and its safety and efficacy have not been fully evaluated by any regulatory authority.”

https://www.sanofi.com/en/media-room/press-releases/2021/2021-09-19-17-30-00-2299392

Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to Insanitary Conditions

admin
-
0
Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to Insanitary Conditions

September 17, 2021: “The U.S. District Court for the Middle District of Florida has entered a consent decree of permanent injunction that prohibits a Florida-based company from producing or distributing any drugs until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements.

According to the complaint, filed by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration (FDA), Premier Pharmacy Labs Inc. and the company’s owner, Vern A. Allen, manufactured and distributed drugs made under insanitary conditions at Premier Pharmacy’s facility, despite multiple warnings from the FDA. Premier stopped manufacturing drugs following an FDA inspection in June 2019.

“Premier Pharmacy and its owner placed patients at significant risk. Outsourcing facilities must follow good manufacturing practice to ensure patients are not exposed to poor quality, potentially harmful drugs,” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.

“We will continue to take appropriate enforcement actions to ensure that companies follow important safety requirements to avoid putting patients’ health at risk.”

The consent decree requires Premier Pharmacy to not engage in any compounding operations or distribution until it completes corrective actions, to ensure the company and its facility are in compliance with the FD&C Act.

Under the consent decree, Premier Pharmacy may not resume compounding operations until it establishes and implements, among other things, a comprehensive quality control system and receives authorization from the FDA.

The complaint alleged that Premier Pharmacy manufactured and distributed drugs, including drugs that were intended to be sterile, that were adulterated because the drugs were made under insanitary conditions and in violation of good manufacturing practice requirements under the FD&C Act. 

Insanitary conditions can cause a compounded drug to become contaminated or otherwise cause patient harm.

According to the complaint, Premier Pharmacy also manufactured and distributed drugs that were neither approved nor exempt from approval because the products did not meet all statutory requirements for outsourcing facilities.

In the spring of 2014, the FDA conducted an inspection of Premier Pharmacy that resulted in a warning letterExternal Link Disclaimer for insanitary conditions and other violations of the FD&C Act.

The FDA conducted a follow-up inspection in June 2016, leading to a regulatory meeting with the company in January 2018. In April 2018, Premier Pharmacy recalled affected sterile injectable products due to potential lack of sterility assurance.

The FDA conducted another follow-up inspection which started in April 2019. In June 2019, following the April inspection and the FDA’s recommendation to recall, Premier Pharmacy recalled all unexpired drugs intended to be sterile.

Premier Pharmacy had been registered as an outsourcing facility for compounded drugs; however, the company deregistered in 2019 and has since stopped compounding drugs.

Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product.

Compounded drugs are not approved by the FDA and, therefore, have not been evaluated for safety or efficacy.“

https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-florida-compounder-prohibiting-manufacture-and

Imfinzi plus chemotherapy tripled patient survival in CASPIAN Phase III in small cell lung cancer

admin
-
0
Imfinzi plus chemotherapy tripled patient survival in CASPIAN Phase III in small cell lung cancer

September 18, 2021: “Updated results from the CASPIAN Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin, demonstrated a sustained, clinically meaningful overall survival (OS) benefit at three years for adults with extensive-stage small cell lung cancer (ES-SCLC) treated in the 1st-line setting.

These data, which show the longest survival update ever reported for an immunotherapy treatment in this setting, were presented during a mini-oral session on 18 September 2021 at the European Society of Medical Oncology (ESMO) Congress 2021.

The CASPIAN trial met the primary endpoint of OS in June 2019, reducing the risk of death by 27% (based on a hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.59-0.91; p=0.0047), which has formed the basis of regulatory approvals in many countries around the world.

Updated results were previously presented during the ASCO20 Virtual Scientific Program in May 2020 with a median follow up of more than two years.

The latest results for Imfinzi plus chemotherapy showed sustained efficacy after a median follow up of more than three years for censored patients, with a 29% reduction in the risk of death versus chemotherapy alone (based on an HR of 0.71; 95% CI 0.60-0.86; nominal p=0.0003). Updated median OS was 12.9 months versus 10.5 for chemotherapy.

The results included a planned exploratory analysis, where an estimated 17.6% of patients treated with Imfinzi plus chemotherapy were alive at three years, versus 5.8% of patients treated with chemotherapy alone.

The survival benefits were consistent across all subgroups, in line with previous analyses.

Luis Paz-Ares, MD, PhD, Chair, Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain and principal investigator in the CASPIAN Phase III trial said: “Patients with extensive-stage small cell lung cancer historically have had limited treatment options and still face a dire prognosis, which makes these data showing that three times as many patients survive three years following Imfinzi treatment especially meaningful.

These results reinforce Imfinzi plus platinum chemotherapy as an important standard of care in this setting.”

Susan Galbraith, Executive Vice President, Oncology R&D, said: “This remarkable improvement in survival is an unprecedented achievement at three years for patients with extensive-stage small cell lung cancer.

We are deeply committed to helping improve survival rates in this disease with research into new treatment options to transform outcomes at various stages, not only with the CASPIAN trial, but also with the ADRIATIC trial in limited-stage disease.”

Imfinzi plus chemotherapy continued to demonstrate a well-tolerated safety profile consistent with the known profiles of these medicines.

Results showed 32.5% of patients experienced a serious adverse event (all causality) with Imfinzi plus chemotherapy versus 36.5% with chemotherapy alone.

Imfinzi in combination with etoposide and either carboplatin or cisplatin is approved in the 1st-line setting of ES-SCLC in more than 55 countries, including the US, Japan, China and across the EU.

Imfinzi is also being tested following concurrent chemoradiation therapy (CRT) in patients with limited-stage SCLC in the ADRIATIC Phase III trial as part of a broad development programme.

In addition, Imfinzi is also approved to treat non-small cell lung cancer (NSCLC) in the curative-intent setting of unresectable, Stage III disease after CRT in the US, Japan, China, across the EU and in many other countries, based on results from the PACIFIC Phase III trial.

Small cell lung cancer
Lung cancer is the leading cause of cancer death among men and women and accounts for about one-fifth of all cancer deaths.

Lung cancer is broadly split into NSCLC and SCLC, with about 15% classified as SCLC.

SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy.

About two-thirds of SCLC patients are diagnosed with extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body.

Prognosis is particularly poor, as prior to the approval of immunotherapy regimens for ES-SCLC, only 7% of all patients with SCLC and only 3% of patients with extensive-stage disease will be alive five years after diagnosis.

CASPIAN
CASPIAN was a randomised, open-label, multi-centre, global Phase III trial in the 1st-line treatment of 805 patients with ES-SCLC.

The trial compared Imfinzi in combination with chemotherapy (etoposide and either carboplatin or cisplatin), or Imfinzi and chemotherapy with the addition of a second immunotherapy, tremelimumab, versus chemotherapy alone.

In the two experimental arms, patients were treated with four cycles of chemotherapy. In comparison, the control arm allowed up to six cycles of chemotherapy and optional prophylactic cranial irradiation.

The trial was conducted in more than 200 centres across 23 countries, including the US, Europe, South America, Asia and the Middle East. The primary endpoint was OS in each of the two experimental arms.

In June 2019, AstraZeneca announced the CASPIAN Phase III trial had met one primary endpoint of demonstrating OS for Imfinzi plus chemotherapy at a planned interim analysis.

In March 2020, however, it was announced that the second experimental arm with tremelimumab did not meet its primary endpoint of OS.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In addition to approvals in ES-SCLC and unresectable, Stage III NSCLC, Imfinzi is approved for previously treated patients with advanced bladder cancer in several countries. Since the first approval in May 2017, more than 100,000 patients have been treated with Imfinzi.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/imfinzi-plus-chemotherapy-tripled-patient-survival-at-three-years-in-the-caspian-phase-iii-trial-in-extensive-stage-small-cell-lung-cancer.html

Imfinzi combined with novel immunotherapies improved clinical outcomes for lung cancer

admin
-
0
Imfinzi combined with novel immunotherapies improved clinical outcomes for lung cancer

September 17, 2021: “Results from the large, randomised COAST Phase II trial showed oleclumab, an anti-CD73 monoclonal antibody, or monalizumab, an anti-NKG2A monoclonal antibody, in combination with Imfinzi (durvalumab) improved progression-free survival (PFS) and objective response rate (ORR) compared to Imfinzi alone in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who had not progressed after concurrent chemoradiation therapy (CRT).

After a median follow-up of 11.5 months, the results of an interim analysis showed Imfinzi in combination with oleclumab reduced the risk of disease progression or death by 56% (hazard ratio [HR] of 0.44; 95% confidence interval [CI] 0.26-0.75), and in combination with monalizumab by 35% (HR of 0.65; 95% CI 0.49-0.85), when compared to Imfinzi alone in Stage III NSCLC patients following CRT.

The 10-month PFS rate was 64.8% for the durvalumab plus oleclumab combination and 72.7% for durvalumab plus monalizumab, versus 39.2% with durvalumab alone.

The results, presented during the European Society for Medical Oncology (ESMO) Congress 2021 today, also showed an increase in the primary endpoint of confirmed ORR for Imfinzi plus oleclumab over Imfinzi alone (30% vs. 18%) and for Imfinzi plus monalizumab over Imfinzi alone (36% vs. 18%).

One in four patients with NSCLC are diagnosed at Stage III, where the majority of tumours are unresectable (cannot be removed with surgery).

Imfinzi after CRT is the global standard of care for patients in this setting, based on the PACIFIC Phase III trial.3-5

Roy S. Herbst, MD, PhD, Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, CT and Chair of the COAST Steering Committee said: “Imfinzi is the established standard of care for patients with unresectable, Stage III NSCLC, but solutions are still needed for patients who do not benefit from currently available therapies.

The remarkable improvement observed with the addition of oleclumab or monalizumab to Imfinzi, along with the strong safety profile, suggests these novel combinations could further redefine outcomes for these patients.”

Susan Galbraith, Executive Vice President, Oncology R&D, said: “Imfinzi has transformed the treatment of patients with unresectable, Stage III NSCLC, and we’re excited by the promise of extending its benefit through novel combinations with two potential first-in-class monoclonal antibodies demonstrating strong clinical activity.

Based on the stand-out results from COAST, we plan to start a registrational trial with the hope of bringing these new treatment options to patients that further increase the potential for cure in this setting.”

Safety was similar across treatment arms with no new safety signals identified for either Imfinzi combination. 

Incidence of Grade 3 or higher treatment-emergent adverse events (TEAE; all cause) were 39.4% with Imfinzi, 40.7% with Imfinzi plus oleclumab, and 27.9% with Imfinzi plus monalizumab.

The most common Grade 3/4 TEAE was dyspnoea (reported in 3.0%, 1.7% and 1.6% of patients, respectively). Grade 3/4 pneumonitis was only reported for one patient (1.6%), who received Imfinzi plus monalizumab.

PACIFIC-real world observational study (PACIFIC-R) demonstrated benefit of Imfinzi in real-world setting at the ESMO Congress 2021
Data from a planned analysis of real-world PFS (rwPFS) from the PACIFIC-R observational study was also presented during ESMO, showing the first effectiveness data from over a thousand patients with unresectable, Stage III NSCLC who were treated with Imfinzi in the real-world setting as part of AstraZeneca’s global PACIFIC Early Access Programme. The analysis showed a median rwPFS of 21.7 months in the real-world setting.

In comparison, a median PFS of 16.9 months was observed among patients treated with Imfinzi in the randomised, double-blinded, placebo-controlled PACIFIC Phase III trial. These results demonstrate the long-term effectiveness of Imfinzi in this real-world patient population and reinforce the PACIFIC regimen as the established standard of care today following platinum-based CRT.

Imfinzi is approved in the curative-intent setting of unresectable, Stage III NSCLC after CRT in the US, Japan, China, across the EU and in many other countries with more than 80,000 patients treated with Imfinzi in this setting since its first approval in February 2018. 

Imfinzi is also approved for the 1st-line treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with etoposide and either carboplatin or cisplatin in more than 55 countries, including the US, Japan, China and across the EU, based on the CASPIAN Phase III trial.

AstraZeneca has several ongoing registrational trials focused on evaluating Imfinzi in earlier stages of lung cancer, including in potentially curative settings (PACIFIC-2, 4 and 5, MERMAID-1 and 2, AEGEAN, ADJUVANT BR.31, and ADRIATIC Phase III trials). The Company is also testing novel combinations with Imfinzi in the Phase II NeoCOAST trial in the neoadjuvant early-stage setting.

Stage III NSCLC
In 2020, an estimated 2.2 million people were diagnosed with lung cancer worldwide.

Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.

Stage III NSCLC represents approximately one quarter of NSCLC incidence.

Stage III (locally advanced) NSCLC is commonly divided into three subcategories (IIIA, IIIB and IIIC), defined by how much the cancer has spread locally.

In contrast to Stage IV, when cancer has spread (metastasised), the majority of Stage III patients are currently treated with curative intent.

The majority of Stage III NSCLC patients are diagnosed with unresectable tumours.

Prior to the approval of Imfinzi in this setting, no new treatments beyond CRT had been available to these patients for decades.

COAST
COAST is a Phase II, multi-arm, randomised trial investigating Imfinzi alone or in combination with either oleclumab (anti-CD73 monoclonal antibody) or monalizumab (anti-NKG2A monoclonal antibody) in 189 patients with locally advanced, unresectable Stage III NSCLC who had not progressed after CRT.

COAST is being conducted in 82 centres across 9 countries in North America, Europe and Asia. The primary endpoint of the trial is ORR.”

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/imfinzi-combined-with-novel-immunotherapies-improved-clinical-outcomes-for-patients-with-unresectable-stage-iii-non-small-cell-lung-cancer.html

Novartis announces findings from alpelisib demonstrating clinical benefit in PROS

admin
-
0
Novartis announces findings from alpelisib demonstrating clinical benefit in PROS

September 17, 2021: “Novartis announced important findings from a real-world study evaluating the safety and efficacy of alpelisib for people living with PIK3CA-Related Overgrowth Spectrum (PROS) who received treatment daily for at least 24 weeks.

Results from EPIK-P1 showed alpelisib effectively reduced volume of clinically significant PROS-related lesions and improved signs and symptoms in pediatric and adult patients. Results were presented at the European Society of Medical Oncology (ESMO) Virtual Congress 2021 [LBA23].

“There are few options available to manage PROS conditions, and they are mainly focused on addressing worsening symptoms.

It is devastating for patients to be without treatments that address the underlying cause of PROS,” said Guillaume Canaud, MD, PhD, Necker-Enfants Malades Hospital – AP-HP, the Paris Descartes University, Inserm (INEM Institute Necker Enfants Malades – Centre for Molecular Medicine).

“The EPIK-P1 findings show robust clinical benefit for adult and pediatric patients and a potential new path forward for those impacted by PROS conditions.”

In EPIK-P1, alpelisib reduced target lesion volume and improved PROS-related symptoms and manifestations.

The primary endpoint analysis conducted at week 24 in patients with complete cases (n=32) showed 38% of patients achieving a response to treatment which was defined as 20% or greater reduction in the sum of PROS target lesion volume.

Nearly three in four patients (74%) showed some reduction in target lesion volume, with a mean reduction of 13.7%, and no patients experienced disease progression at time of primary analysis.

Additionally, at week 24, investigators reported patient improvements from baseline in pain (90%), fatigue (76%), vascular malformation (79%), limb asymmetry (69%), and disseminated intravascular coagulation (55%) across the full study population (n=57).


“Thanks to the data from patients and physicians included in the analysis of EPIK-P1, we have findings to help validate the potential of alpelisib in PROS and have taken an important step toward reimagining medicine for the PROS community,” said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development. “We will continue to discuss this real-world evidence with the FDA in an effort to bring this treatment to people in need as quickly as possible.”


Adverse events (AEs) and treatment-related AEs (TRAEs) were experienced by 83% and 39% of patients, respectively. Most AEs were mild to moderate in severity, and there were no AEs leading to treatment discontinuation.

The most common AEs of any grade were diarrhea (16%), hyperglycemia (12%), aphthous ulcers (11%), and stomatitis (5%).

The most common grade 3/4 AE was cellulitis (4%); one adult case was considered treatment-related.

PROS is a wide-ranging spectrum of disorders caused by a mutation in the PIK3CA gene. PROS conditions are rare and visually diverse, and are typically characterized by atypical growths and anomalies in blood vessels, the lymphatic system and other tissues.

PROS conditions can look different from each other in size, shape, and type of growth or malformation based on where in the body the mutation is found.

PROS can disrupt mobility and cognitive function in some patients and may lead to life-threatening complications.

There are no approved medical therapies for PROS conditions. PROS management varies by patient, and surgery and radiologic embolization are common with patients often undergoing multiple procedures due to frequent regrowth following surgery.

There is a significant need for treatment options for PROS that reduce overgrowth, address symptoms, and improve quality of life.3,9-10

The U.S. Food and Drug Administration (FDA) granted alpelisib Breakthrough Therapy Designation on November 13, 2019, and discussions with FDA about alpelisib for PROS are ongoing.

About PIK3CA-Related Overgrowth Spectrum (PROS)
The PROS classification was proposed at the National Institutes of Health in a workshop in 2013 to unite a group of rare overgrowth conditions caused by PIK3CA mutations.

Specific conditions associated with PROS include KTS, CLOVES syndrome, ILM, MCAP/M–CM, HME, HHML, FIL, FAVA, macrodactyly, muscular HH, FAO, CLAPO syndrome and epidermal nevus, benign lichenoid keratosis, or seborrheic keratosis.

The estimated prevalence of PROS conditions is approximately 14 people per million.”

https://www.novartis.com/news/media-releases/novartis-announces-findings-from-real-world-study-alpelisib-demonstrating-clinical-benefit-people-pik3ca-related-overgrowth-spectrum-pros

1...454647...157Page 46 of 157

EDITOR PICKS

POPULAR POSTS

POPULAR CATEGORY

ABOUT US

LifeProNow provides guidance and high quality contents to help job seekers to get their dream Job. All the contents are written by experienced folks and peer reviewed by experts.

Contact us: [email protected]

FOLLOW US

© LifeProNow | All Rights Reserved