FDA Grants Breakthrough Therapy Designation to Merck for KEYTRUDA® (pembrolizumab) in Classical Hodgkin Lymphoma (cHL)


April 18, 2016

Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to KEYTRUDA® (pembrolizumab). This is the company’s anti-PD-1 therapy which is used for the treatment of patients with refractory or relapsed classical Hodgkin lymphoma (cHL). This is the fourth Breakthrough Therapy Designation granted for KEYTRUDA.

As said by Dr. Roger M. Perlmutter, president, Merck Research Laboratories: “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. 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.”

This Breakthrough Therapy Designation from FDA is intended to accelerate the development and review of a candidate that is planned for use, alone or in combination, to treat a life-threatening or serious disease or condition when preliminary clinical evidence shows that the drug may demonstrate considerable improvement over existing therapies on one or more clinically significant endpoints. Previously, KEYTRUDA was granted breakthrough status for specific patients with advanced non-small cell lung cancer (NSCLC), advanced melanoma, and advanced colorectal cancer.

FDA Grants Breakthrough Therapy Designation to Merck for KEYTRUDA® (pembrolizumab) in Classical Hodgkin Lymphoma (cHL) last edit: 2016-05-10T18:00:36+00:00 da Luca

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