The U.S. Food and Drug Administration has assigned Priority Review to the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), whose tumors express PD-L1.1
The FDA has also granted Breakthrough Therapy Designation for this indication. It is expected to respond to the application by December 24, 2016.
The sBLA is based on findings from the pivotal phase 3 KEYNOTE-024 study, which demonstrated a superior progression-free survival and overall survival with single-agent pembrolizumab, in contrast with standard chemotherapy, among patients with PD-L1-positive advanced NSCLC. The trial was stopped early so that patients receiving chemotherapy could receive pembrolizumab.
Pembrolizumab, a PD-1-blocking monoclonal antibody, is indicated for the treatment of patients with advanced NSCLC whose tumors express PD-L1 and have disease progression on or after platinum-containing chemotherapy.
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It is also approved for patients with advanced melanoma and patients with advanced head and neck squamous cell carcinoma who have disease progression on or after platinum-containing chemotherapy.
- FDA accepts supplemental Biologics License Application, assigns Priority Review and grants Breakthrough Therapy Designation to Merck’s Keytruda (pembrolizumab) for first-line treatment of patients with advanced non-small cell lung cancer [press release]. Merck website. http://www.mercknewsroom.com/news-release/oncology-newsroom/fda-accepts-supplemental-biologics-license-application-assigns-priori. Updated September 7, 2016. Accessed September 9, 2016.