Merck & Co's melanoma drug Keytruda becomes first FDA-approved anti-PD-1 therapy

The US Food and Drug Administration has granted accelerated approval for pharma giant Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs, the agency announced late yesterday. Merck’s shares gained 1.1% to $60.72 in after-hours trading.

Keytruda is the first approved drug that blocks a cellular pathway known as PD-1 (programmed death receptor-1), which restricts the body’s immune system from attacking melanoma cells. Keytruda is intended for use following treatment with ipilimumab (Bristol-Myers Squibb’s Yervoy), a type of immunotherapy. For melanoma patients whose tumors express a gene mutation called BRAF V600, Keytruda is intended for use after treatment with ipilimumab and a BRAF inhibitor, a therapy that blocks activity of BRAF gene mutations.

Merck says it is conducting ongoing Phase II and III clinical studies in advanced melanoma, which are designed to provide further confirmatory evidence for Keytruda in this indication. Merck plans to make the drug available within one week from yesterday’s FDA approval.