Merck announced that the FDA has accepted for review a supplemental Biologics License Application (sBLA) for Keytruda, 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 (NSCLC), regardless of PD-L1 expression.
This sBLA, which is seeking accelerated approval for this new indication, is based on data from the Phase 3 Keytruda-407 trial, which were recently presented at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting. The FDA has granted Priority Review to this sBLA and set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 30, 2018.
“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,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We are pleased that our application for squamous cell carcinoma—a historically challenging-to-treat disease—is under priority review with the FDA.”
In lung cancer, Merck has an extensive clinical development program and is advancing multiple registration-enabling studies with Keytruda in combination with other treatments and as monotherapy. The program, which is comprised of nearly 9,000 patients across 15 Merck-sponsored clinical studies, is evaluating Keytruda across multiple settings and stages of the disease.
Filed Under: Drug Discovery