The U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) that is seeking approval for pembrolizumab (Keytruda) for the treatment of patients with refractory classical Hodgkin lymphoma or those who had relapsed after 3 or more prior lines of treatment.1
The application will seek approval for the drug at a 200 mg fixed dosage delivered intravenously every 3 weeks, with a target action date by the FDA of March 15, 2017. This is the first time the drug, which is manufactured by Merck, has sought regulatory approval for a hematologic malignancy.
The decision is based on trials evaluating responses of patients with refractory classical Hodgkin lymphoma or patients who had relapsed after 3 or more prior lines of therapy.
The FDA previously granted Breakthrough Therapy Designation to pembrolizumab for the same indication in April 2016.
In a release, Merck has stated that it is “conducting broad immune-oncology research assessing the role of monotherapy and combination regimens” for pembrolizumab in the treatment of hematologic malignancies. A clinical development program of pembrolizumab includes about 200 trials that look at the application of the drug in the treatment of a variety of cancer types.
- FDA grants priority review to supplemental biologics license application (sBLA) for Merck’s KEYTRUDA (pembrolizumab) in relapsed or refractory classical Hodgkin lymphoma. Merck website. http://www.mercknewsroom.com/news-release/oncology-newsroom/fda-grants-priority-review-supplemental-biologics-license-application. Updated December 1, 2016. Accessed December 1, 2016.