> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Merck Keytruda sBLA Accepted for Melanoma
- URL: https://www.fdaweb.com/merck-keytruda-sbla-accepted-for-melanoma/
- Published: 2018-06-26T12:00:00.000Z
- Updated: 2026-09-15T00:15:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141772

FDA has accepted for review a Merck supplemental BLA for Keytruda, an anti-PD-1 infusion treatment for use as adjuvant therapy for patients with resected, high-risk stage melanoma. The submission is based on data from the Phase 3 EORTC1325/ KEYNOTE-054 trial that showed a significant benefit in recurrence-free survival for patients taking Keytruda. The agency has set a user fee review action target of 2/16/2019.