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# FDA Accepts 2 Merck sBLAs for Keytruda
- URL: https://www.fdaweb.com/fda-accepts-2-merck-sblas-for-keytruda/
- Published: 2017-02-03T12:00:00.000Z
- Updated: 2026-09-14T22:04:37.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5137902

FDA has accepted for review two Merck supplemental BLAs for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy in patients with locally advanced or metastatic urothelial cancer. Specifically, the application for first-line use was accepted and granted priority review for treating patients who are ineligible for cisplatin-containing therapy. The application for second-line use was granted priority review for these patients with disease progression on or after platinum-containing chemotherapy. The user fee target review date for both applications is 6/14.

  
Keytruda is currently approved in lung cancer for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score of 50% or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations; and for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS of 1% or more) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.