> ## 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 sBLA for Keytruda for Rare Skin Cancer
- URL: https://www.fdaweb.com/merck-sbla-for-keytruda-for-rare-skin-cancer/
- Published: 2018-09-04T12:00:00.000Z
- Updated: 2026-09-15T00:29:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142264

FDA has accepted for priority review a Merck supplemental BLA seeking accelerated approval for Keytruda for treating adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). The submission is based on data from the Phase 2 KEYNOTE-017 trial that evaluated the overall response rate and duration of response. The agency has set a user fee review action target of 12/28.

MCC is an aggressive and rare form of skin cancer that is often caused by a Merkel cell-associated polyomavirus. More than 90% of people diagnosed with MCC are older than 50 years of age, according to Merck, and it is more likely to spread to other parts of the body than most types of skin cancer.