FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Advanced Melanoma
Posted on December 22, 2015
KEYTRUDA is Now the First and Only Anti-PD-1 Therapy to Achieve Superior Overall Survival Compared to Ipilimumab
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, to include the first-line treatment of patients with unresectable or metastatic melanoma. This approval marks the second FDA-approved indication in advanced melanoma for KEYTRUDA, which is now the first anti-PD-1 therapy approved for previously untreated advanced melanoma patients regardless of BRAF status. The FDA-approved dose of KEYTRUDA is 2 mg/kg every three weeks.