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# Priority Review for Merck Keytruda sBLA
- URL: https://www.fdaweb.com/priority-review-for-merck-keytruda-sbla/
- Published: 2019-02-15T12:00:00.000Z
- Updated: 2026-09-15T01:04:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143400

FDA has accepted for priority review a Merck supplemental BLA for Keytruda for use in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The submission is based on findings from the Phase 3 KEYNOTE-426 trial, which demonstrated that Keytruda in combination with axitinib, as compared to sunitinib, significantly improved overall survival and progression-free-survival in the first-line treatment of advanced RCC, according to the company. It also included supporting data from the Phase 1b KEYNOTE-035 trial. FDA has set a 6/20 user fee review action target date.