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# FDA Approves New Keytruda Indication
- URL: https://www.fdaweb.com/fda-approves-new-keytruda-indication/
- Published: 2021-11-18T12:00:00.000Z
- Updated: 2026-09-14T17:22:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150607

FDA has approved a new indication for Merck’s Keytruda for adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions. The company [says](https://www.merck.com/news/fda-approves-mercks-keytruda-pembrolizumab-as-adjuvant-therapy-for-certain-patients-with-renal-cell-carcinoma-rcc-following-surgery/?ref=fdaweb.com) the approval is based on data from the pivotal Phase 3 KEYNOTE-564 trial in which Keytruda demonstrated a statistically significant improvement in disease-free survival compared to placebo.

Merck says Keytruda is an anti-programmed death receptor-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. It is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes that may affect both tumor cells and healthy cells. It has multiple FDA-approved indications.