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# FDA Accepts Keytruda sBLA, Sets Priority Review
- URL: https://www.fdaweb.com/fda-accepts-keytruda-sbla-sets-priority-review/
- Published: 2021-08-05T12:00:00.000Z
- Updated: 2026-09-14T17:09:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149875

Based on data from the Phase 3 KEYNOTE-716 trial of Merck’s Keytruda (pembrolizumab), FDA has accepted the company’s sBLA for the adjuvant treatment of adults and children age 12 and older with stage 2B or 2C melanoma following complete resection. The agency says it will give the sBLA priority review and assigned a PDUFA target action date of 12/4.

The company [says](https://www.merck.com/news/mercks-keytruda-pembrolizumab-significantly-prolonged-recurrence-free-survival-rfs-compared-to-placebo-as-adjuvant-therapy-for-patients-with-stage-ii-resected-high-risk-melanoma-in/?ref=fdaweb.com) Keytruda met its primary endpoint of recurrence-free survival for the adjuvant treatment of patients with surgically resected high-risk stage 2 melanoma.

Keytruda is described as an anti-programmed death receptor therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. It is already approved for several indications in the U.S.