Merck MRK announced that the FDA has issued a complete response letter (“CRL”) to its supplemental Biologics License Application (sBLA) for its multi-cancer drug, Keytruda. The sBLA was seeking label expansion of the drug as neoadjuvant and adjuvant treatment for patients with high-risk early-stage triple-negative breast cancer (TNBC). The company was seeking a combination of Keytruda with chemotherapy for neoadjuvant treatment, followed by Keytruda monotherapy for adjuvant treatment after surgery.
The sBLA was filed based on data on pathologic complete response (pCR)and early interim event-free survival from the ongoing phase III study — KEYNOTE-522. Recently, the FDA’s Oncologic Drugs Advisory Committee voted for deferral of regulatory decision on the TNBC sBLA for Keytruda until further data are available from the late-stage study. The company is reviewing the CRL and will discuss future regulatory steps for the sBLA.
We note that the next interim-analysis of the study will occur in the third quarter of 2021. The issuance of the CRL by the FDA is likely due to unavailability of sufficient data. We assume a potential approval for Keytruda in TNBC indication will come after the next interim-analysis.
Among different cancers, Keytruda is already approved in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic TNBC patients with tumors expressing PD-L1. However, the recent CRL will have no impact on this indication as well as other approved indications.
Shares of Merck have lost 4.3% so far this year against the industry’s increase of 0.7%.
We note that Keytruda, which is Merck’s major revenue-generating product, is already approved for use in more than 30 indications across several different tumor types. The drug recorded sales of $14.4 billion in 2020, up 30% year over year. Keytruda sales have been gaining momentum through constant label expansion and the launch of new indications globally.
The Keytruda development program is also progressing well with Merck spending billions on research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being evaluated in more than 1400 studies including several combination studies. Merck has collaborated with several companies including Amgen AMGN, Incyte, Glaxo GSK and Pfizer PFE, separately, for the evaluation of Keytruda in combination with other regimens.
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
Zacks Rank
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
See these 7 breakthrough stocks now>>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Pfizer Inc. (PFE) : Free Stock Analysis Report
Merck & Co., Inc. (MRK) : Free Stock Analysis Report
To read this article on Zacks.com click here.
"breast" - Google News
March 30, 2021 at 08:51PM
https://ift.tt/3m692Lu
Merck's (MRK) Breast Cancer sBLA for Keytruda Gets CRL - Yahoo Finance
"breast" - Google News
https://ift.tt/2ImtPYC
https://ift.tt/2Wle22m
Bagikan Berita Ini
0 Response to "Merck's (MRK) Breast Cancer sBLA for Keytruda Gets CRL - Yahoo Finance"
Post a Comment