US EditionMerck's Keytruda Secures FDA Nod For Head And Neck Cancer As First Immunotherapy For Use Around Surgery - Merck & Co (NYSE:MRK)
- On June 14, 2025, the FDA authorized Merck's Keytruda for use in adult patients with surgically removable, stage 3 or 4A tumors of the head and neck region that test positive for PD-L1.
- This approval followed results from the randomized KEYNOTE-689 trial, which tested perioperative pembrolizumab combined with standard care against standard care alone in 714 patients with stage 3 or 4A HNSCC.
- The study showed pembrolizumab significantly extended median event-free survival to 59.7 months versus 29.6 months for controls, with higher rates of tumor destruction observed in surgical specimens.
- Keytruda did not delay surgery or cause new safety concerns, and the approval marks the first FDA green light for a perioperative checkpoint inhibitor in this cancer type in over two decades.
- Experts call this a major shift in management of surgically treated head and neck cancer, which may reduce recurrence risk and improve patient outcomes with integrating immunotherapy earlier.
15 Articles
15 Articles
FDA approves pembrolizumab for resectable head and neck cancer with PD-L1 expression
Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.
Merck's Keytruda Secures FDA Nod For Head And Neck Cancer As First Immunotherapy For Use Around Surgery - Merck & Co (NYSE:MRK)
The U.S. Food and Drug Administration (FDA) on Friday approved Merck & Co Inc.’s (NYSE:MRK) Keytruda (pembrolizumab) for adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score of at least 1), as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent…
MedPage Today
Anti-Aging, Acupuncture and Health NewsFDA OKs Perioperative Immunotherapy for Head and Neck Cancer
(MedPage Today) -- The FDA approved pembrolizumab (Keytruda) for patients with PD-L1-positive resectable locally advanced head and neck squamous cell carcinoma as neoadjuvant monotherapy, continued as adjuvant therapy plus radiotherapy with or...
FDA Approves Immune Checkpoint Inhibitor Drug for Patients with Resectable Locally Advanced Head and Neck Cancer, Backed by Dana-Farber Research
Pembrolizumab, an immune checkpoint inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.
Chicago – For decades, the standard treatment for patients with resected, locally advanced head and neck squamous cell carcinoma (LA-SCCHN) and high risk of recurrence has been adjuvant cisplatin plus radiation. As Jean Bourhis, Bâtiment Hospitalier, Lausanne, reported at the ASCO Annual Meeting in Chicago, the addition of...
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