FDA Accepts Merck’s Keytruda for Review, Sets PDUFA Date
Merck shares retreated to start off the week despite the announcement of good news from the FDA.
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Merck & Co. Inc. (NYSE: MRK) shares retreated to start off the week after the firm announced that the U.S. Food and Drug Administration (FDA) has accepted Keytruda for review for a supplemental Biologics License Application (sBLA). This is Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer.
This sBLA, which is seeking accelerated approval for this new indication, is based on data from the Phase 3 KEYNOTE-407 trial, which were recently presented at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting.
Looking ahead, the FDA has granted Priority Review to this sBLA and set a Prescription Drug User Fee Act (PDUFA) date for October 30, 2018.
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Dr. Roy Baynes, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, commented:
KEYTRUDA has already been established as an important treatment option for non-small cell lung cancer in the first-line setting, and with our broad development program in lung cancer, we are committed to improving survival for as many patients as we can. We are pleased that our application for squamous cell carcinoma – a historically challenging-to-treat disease – is under priority review with the FDA.
So far in 2018, Merck has outperformed the broad markets, with its stock up about 8%. Over the past 52 weeks, the stock is actually down about 6%.
Shares of Merck were last seen up down fractionally at $60.40, with a consensus analyst price target of $69.06 and a 52-week range of $52.83 to $66.41.
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Chris Lange is a financial and geopolitical writer with more than a decade of experience covering a myriad of topics. He has published thousands of articles for 24/7 Wall St., with past coverage focused heavily on stocks, IPOs, healthcare, defense, global affairs, and technology.
His work has been quoted, or referenced by a number of outlets including Business Insider, USA Today, Yahoo Finance, MSN, The Motley Fool, and many other publications. A graduate of Southwestern University, he studied business with a focus on investments and has previous experience in banking and startups.
When not reading or writing the news, he is following his passion for Lacrosse, playing chess, or building solar projects with his dad.
