FDA approves Keytruda for Metastatic Melanoma-Merck

The FDA has given accelerated approval for Keytruda (pembrolizumab), from Merck, at a dose of 2 mg/kg 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. The approval was based on data from a multi-center, open-label, randomized, dose-comparative study cohort of the ongoing KEYNOTE-001 Phase 1b trial in patients with unresectable or metastatic melanoma and progression of disease.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In clinical trials, 24 percent of patients taking pembrolizumab had their tumors shrink. Most of these patients continued to respond past the 8.5 month study cut off. Merck is conducting ongoing Phase 2 and 3 clinical studies in advanced melanoma, which are designed to provide further confirmatory evidence for Keytruda in this indication. Merck plans to make Keytruda available within one week from today�s FDA approval.