> ## 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.

# FDA Approves 2 New Indications for Merck’s Keytruda
- URL: https://www.fdaweb.com/fda-approves-2-new-indications-for-mercks-keytruda/
- Published: 2017-05-19T12:00:00.000Z
- Updated: 2026-09-14T22:24:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138741

FDA has approved two new indications for Merck’s Keytruda (pembrolizumab) for treating certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. One indication is for first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. The other indication is for second-line treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. “Keytruda is approved for use in these indications at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression,” the company says.