Merck's MK-3475 Biologics License Application Up For FDA Priority Review
Merck announced that its Biologics License Application (BLA) for its MK-3475 has been accepted by the U.S Food and Drug Administration (FDA) under a Priority Review designation. The FDA granted a PDUFA date of October 28, 2014 for the MK-3475 BLA under the agency’s accelerated approval program.
MK-3475 is Merck’s investigational anti-PD1 antibody for the treatment of unresectable or metastatic melanoma in patients with a history of ipilimumab treatment. The FDA has previously awarded the investigational drug Breakthrough Therapy designation for advanced melanoma. If approved, Merck’s MK-3475 will potentially be the first anti-PD-1 antibody in a novel class of immune checkpoint modulators.
Dr. Roger M. Perlmutter, President of Merck Research Laboratories, said, “Patients with advanced melanoma have few therapeutic options and often fail to respond to all available treatments. We are hopeful that the FDA, through their priority review of our application, will agree to make MK-3475 available to patients with advanced melanoma who have no other therapeutic options.”
The MK-3475 development program is currently ongoing investigations in 30 tumor types both as monotherapy and in combination. Ongoing and scheduled late-stage studies include seven Phase III registrational trials covering advanced melanoma, advanced non-small cell lung cancer (previously-treated and previously-untreated), advanced head and neck cancer, and advanced bladder cancer. The program will also include ten combination studies in HER2+ breast cancer, advanced melanoma, advanced renal cell carcinoma, and other solid tumors.
Dr. Perlmutter stated that the program’s goal is to advance breakthrough immunomodulatory molecules to uncover the immune system’s ability to target and destroy cancer cells. “While MK-3475 provides a firm foundation for Merck’s research and development strategy in oncology, we are also advancing a broad pipeline of immune checkpoint agonists and antagonists,” he said.
The company said it intends to submit a Marketing Authorization Application for the investigational cancer drug in Europe for advanced melanoma by the end of the year.