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FDA Approval Alert: Merck’s pembrolizumab (Keytruda) Approved for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (June 12, 2025)
On June 12, 2025, the FDA approved pembrolizumab (Keytruda) for the treatment of resectable locally advanced head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1. The drug is a PD-1 checkpoint inhibitor and was approved based on data from KEYNOTE-689 (Phase III).
Disease Overview: Head and Neck Squamous Cell Carcinoma (HNSCC)
HNSCC arises in the oral cavity, pharynx, and larynx. Treatment often combines surgery, radiation, and chemotherapy for locally advanced disease. Immunotherapy options are expanding for selected patients.
Treatment Resume
- Drug Name: pembrolizumab (Keytruda)
- Company: Merck
- Approval Date: June 12, 2025
- Indication: Resectable Locally Advanced HNSCC with PD-L1 CPS ≥1
- Mechanism: PD-1 checkpoint inhibitor
- Pivotal Trial: KEYNOTE-689 (Phase III)
- Key Outcome: EFS improvement (HR 0.70, p=0.00140)
Patient-Friendly Explanation
Keytruda helps enhance immune response against cancer cells, reducing recurrence risk when given around the time of surgery.
M&A Information
- Subsidiary Info: Not applicable (Merck in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Info: Public Investors (NYSE: MRK)
Reference
This approval information is based on Drugs@FDA (U.S. Food and Drug Administration).
