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# FDA Priority Review for Merck sBLA for Keytruda
- URL: https://www.fdaweb.com/fda-priority-review-for-merck-sbla-for-keytruda/
- Published: 2017-01-11T12:00:00.000Z
- Updated: 2026-09-14T21:59:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137697

FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, plus chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberrations. The agency has set a user fee review target date of 5/10.

The submission is based on data from the study KEYNOTE-021, Part 2, Cohort G, that studied 123 previously untreated patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and regardless of PD-L1 expression. Keytruda is currently approved in lung cancer for the first-line treatment of patients with metastatic 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.