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# Merck’s Keytruda OK’d for Bladder Cancer
- URL: https://www.fdaweb.com/mercks-keytruda-okd-for-bladder-cancer/
- Published: 2020-01-08T12:00:00.000Z
- Updated: 2026-09-14T15:57:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145794

FDA has approved Merck’s Keytruda (pembrolizumab) for treating patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma *in situ* (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Approval was based on data from the KEYNOTE-057, a multicenter, single-arm trial that enrolled 148 patients with high-risk NMIBC, 96 of whom had BCG-unresponsive CIS with or without papillary tumors, an FDA [release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer?ref=fdaweb.com) says.  

The release says that the complete response rate in the 96 patients with high-risk BCG-unresponsive NMIBC with CIS was 41%, and median response duration was 16.2 months. “Forty-six percent of responding patients experienced a complete response lasting at least 12 months,” it says.

The agency says that the most common adverse reactions (incidence greater than 10%) in patients who received pembrolizumab in KEYNOTE-057 were fatigue, diarrhea, rash, pruritis, musculoskeletal pain, hematuria, cough, arthralgia, nausea, constipation, urinary tract infection, peripheral edema, hypothyroidism, and nasopharyngitis.