FDA grants priority review to Keytruda for first-line treatment of advanced melanoma

Source: Healio.com/hematology-oncology, August 2015

The FDA granted priority review to pembrolizumab for the first-line treatment of patients with unresectable or metastatic melanoma, according to a press release from the drug’s manufacturer.

Pembrolizumab (Keytruda, Merck) is currently approved in the U.S. at a dose of 2 mg/kg administered as an IV infusion over 30 minutes every 3 weeks for the treatment of patients with unresectable or metastatic melanoma whose disease progressed following treatment with ipilimumab (Yervoy, Bristol-Myers Squibb) or, if the patient is BRAF V600 positive, a BRAF inhibitor.

The FDA accepted a supplemental biologics license application for pembrolizumab at the currently approved dose in the first-line setting with a priority review target action date of December 19, 2015.

Further, the FDA extended the action date to December 24, 2015 for a separate supplemental biologics license application for pembrolizumab in patients with ipilimumab-refractory advanced melanoma.

“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,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a press release.