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# FDA Approves Merck’s Keytruda for Some Breast Cancers
- URL: https://www.fdaweb.com/fda-approves-mercks-keytruda-for-some-breast-cancers/
- Published: 2021-07-27T12:00:00.000Z
- Updated: 2026-09-14T17:07:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149795

FDA has approved Merck’s Keytruda (pembrolizumab) for treating patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. The company [says](https://www.marketwatch.com/press-release/fda-approves-keytruda-pembrolizumab-for-treatment-of-patients-with-high-risk-early-stage-triple-negative-breast-cancer-in-combination-with-chemotherapy-as-neoadjuvant-treatment-then-continued-as-single-agent-as-adjuvant-treatment-after-surgery-2021-07-27?tesla=y&ref=fdaweb.com) the approval is based on the Phase 3 KEYNOTE-522 trial that showed Keytruda in combination with carboplatin and paclitaxel, followed by doxorubicin or epirubicin and cyclophosphamide before surgery and continued as a single agent after surgery significantly prolonged event-free survival versus the same neoadjuvant regimens alone in patients with previously untreated stage 2 or 3 TNBC. The company says Keytruda is now approved in the U.S. for 30 indications.