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# Merck’s Keytruda Approved for Melanoma
- URL: https://www.fdaweb.com/mercks-keytruda-approved-for-melanoma/
- Published: 2019-02-20T12:00:00.000Z
- Updated: 2026-09-15T01:06:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143426

FDA has approved Merck’s Keytruda (pembrolizumab) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes following complete resection. Approval is based on results from the EORTC1325/KEYNOTE-054 trial, which demonstrated that Keytruda significantly prolonged recurrence-free survival. It was also shown to reduce the risk of disease recurrence or death by 43% compared to placebo in patients with resected, high-risk Stage III melanoma.

The company says that immune-mediated adverse reactions, which may be severe or fatal, can occur with Keytruda, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Based on the severity of the adverse reaction, Keytruda should be withheld or discontinued and corticosteroids administered if appropriate, it adds.