FDA to review biologics license application for Merck’s MK-3475 for metastatic melanoma

The FDA has accepted for review the biologics license application for an investigational anti-PD-1 antibody for treating unresectable or metastatic melanoma in patients treated with ipilimumab, Merck announced.

“Patients with advanced melanoma have few therapeutic options and often fail to respond to all available treatments,” Roger M. Perlmutter, MD, PhD, Merck Research Laboratories president, said in a news release. “We are hopeful that the FDA, through their priority review … will agree to make MK-3475 available to patients with advanced melanoma who have no other therapeutic options.”

The FDA Priority Review designation includes a Prescription Drug User Fee Act date of Oct. 28, with the biologics license application to be reviewed under the FDA’s Accelerated Approval program, the release said. MK-3475, which had previously been granted Breakthrough Therapy designation by the FDA for advanced melanoma, has the “potential to be the first anti-PD-1 antibody in a new class of immune checkpoint modulators,” according to the release.

As MK-3475 develops, Merck anticipates growth to more than 24 clinical trials across 30 different tumor types with an estimated 6,000 patients at 300 clinical sites worldwide by the end of the year, the release said. Seven phase 3 registrational trials planned or ongoing include treatment of advanced melanoma (adjuvant, ipilimumab-naive and ipilimumab-refractory), advanced nonsmall cell lung cancer (previously treated or untreated), advanced head and neck cancer, and advanced bladder cancer.

“Our priority is advancing breakthrough immunomodulatory molecules that reveal the ability of the immune system to eliminate cancer cells,” Perlmutter said.

Merck also announced its plans to file a marketing authorization application in Europe for MK-3475 for advanced melanoma by the end of the year.