Merck: FDA Accepts SBLA For KEYTRUDA - Quick Facts

(RTTNews) - Merck (MRK) announced the U.S. FDA has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy. The company 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.

Merck also reported that 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.

KEYTRUDA is currently indicated in the U.S. 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.