The U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) seeking approval for pembrolizumab (Keytruda) for the treatment of patients with advanced microsatellite instability-high (MSI-H) cancer.1
The FDA will review the sBLA under its Accelerated Approval program based on tumor response rate and durability of response, requiring the FDA to take action on the application by March 8, 2017.
The FDA previously granted Breakthrough Therapy Designation to pembrolizumab for unresectable or metastatic MSI-H colorectal and non-colorectal cancers.
The application includes data from 5 open-label, multi-cohort, multicenter phase 1/2 trials investigating the activity of pembrolizumab in MSI-H cancer. Merck, the drug’s developer, is seeking approval for a fixed 200 mg dose of pembrolizumab given every 3 weeks.
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MSI is caused by a deficiency in a cell’s ability to repair errors in the DNA sequence (mismatch repair) that occurs during cell division, resulting in a characteristic change in the short repetitive sequences of DNA. MSI-H is already an established biomarker in some types of cancer, including colorectal cancer.
- FDA grants Priority Review to Merck’s supplemental Biologics License Application (sBLA) seeking approval for Keytruda (pembrolizumab) for new indication in microsatellite instability-high cancer. Merck website. http://www.mercknewsroom.com/news-release/oncology-newsroom/fda-grants-priority-review-mercks-supplemental-biologics-license-appl. Updated November 28, 2016. Accessed November 29, 2016.