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FDA grants breakthrough therapy designation to Keytruda for Hodgkin lymphoma
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The FDA granted breakthrough therapy designation to pembrolizumab for the treatment of relapsed or refractory classical Hodgkin lymphoma, according to a press release from the drug’s manufacturer.
The decision was based, in part, on data from the ongoing phase 1b KEYNOTE-013 study — presented at the ASH Annual Meeting and Exposition in 2015 — and phase 2 KEYNOTE-087 study, both of which are evaluating pembrolizumab (Keytruda, Merck) as a single agent for patients with classical Hodgkin lymphoma. Results from KEYNOTE-087 will be presented at an upcoming medical meeting, according to the release.
Pembrolizumab — an anti–PD-1 therapy — also received breakthrough therapy designation for advanced melanoma, advanced non–small cell lung cancer and advanced colorectal cancer.
Roger M. Perlmutter
“Merck has launched an ambitious clinical development program examining the efficacy of Keytruda in a broad range of solid and blood cancers, and our studies of relapsed or refractory classical Hodgkin lymphoma are quite promising,” Roger M. Perlmutter, MD, PhD, president of Merck Research Laboratories, said in the release. “The FDA’s Breakthrough Designation for this blood cancer provides an important mechanism to assist us in bringing this immunotherapy to patients who could benefit from its use.”