FDA Grants Merck's Keytruda Fourth Breakthrough Designation

Apr 19, 2016


The U.S. FDA has granted Breakthrough Therapy Designation to Merck's Keytruda, the company's anti-PD-1 therapy, for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma or cHL. 

This is the fourth Breakthrough Therapy Designation granted for Keytruda, which potentially speeds up the regulatory pathway for the drug in this indication. Keytruda was previously granted breakthrough status for specific patients with advanced melanoma, advanced non-small cell lung cancer (NSCLC), and advanced colorectal cancer.

Keytruda is already approved in the U.S. for unresectable or metastatic melanoma as well as for some patients with non-small cell lung cancer.

Keytruda’s (pembrolizumab) Breakthrough Therapy Designation in cHL is based on data from the ongoing Phase Ib KEYNOTE-013 and Phase II KEYNOTE-087 studies evaluating the drug as a single agent in patients with cHL, and signals the agency’s belief that it might offer a substantial improvement over existing therapies on one or more clinically significant endpoints.

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