FDA Accepts sBLA for Keytruda, Merck’s Anti-PD-1 Therapy, for First-Line Treatment of Advanced Melanoma, and Grants Priority Review

Merck (MSD) has announced 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 3 weeks, for the first-line treatment of unresectable or metastatic melanoma patients. FDA granted Priority Review with a PDUFA, or target action, date of 19 December 2015. In addition, 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 24 December 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 US at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every 3 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 tumour 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 III 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