Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 therapy. Merck is seeking approval for KEYTRUDA, at the currently approved dose of 2 mg/kg every three weeks, for the first-line treatment of unresectable or metastatic melanoma patients. The FDA granted Priority Review with a PDUFA, or target action, date of December 19, 2015. Additionally, the FDA has extended the action date for a separate sBLA for KEYTRUDA for the treatment of patients with ipilimumab-refractory advanced melanoma. The new action date is now December 24, 2015.

“Through our clinical program for KEYTRUDA we have accumulated substantial data on the role of our anti-PD-1 therapy in advanced melanoma. We look forward to the FDA’s review of each of these applications, and to delivering on our goal of helping patients with advanced melanoma to achieve long-term disease control and survival,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories.

KEYTRUDA is currently indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

The sBLA submission for first-line use in advanced melanoma was based in part on data from KEYNOTE-006, a Phase 3 study which evaluated KEYTRUDA in 834 patients with unresectable or metastatic melanoma with progression of disease. Findings from this study were presented at the 2015 American Associated for Cancer Research (AACR) Annual Meeting and published in the New England Journal of Medicineⁱ.

Update on sBLA in Ipilimumab-Refractory Advanced Melanoma

The sBLA for ipilimumab-refractory advanced melanoma included data from KEYNOTE-002. KEYNOTE-002 is the Phase 2 study which demonstrated KEYTRUDA was superior to chemotherapy in helping more patients with ipilimumab-refractory advanced melanoma achieve progression-free survival (PFS). In an effort to provide the FDA with the most robust data for KEYTRUDA in this population, Merck submitted an additional analysis from KEYNOTE-002. The submission constitutes a major amendment which will require additional time for review.