Pembrolizumab Approved for Head & Neck Cancer | FDA
- Teh U.S.Food and Drug Governance (FDA) has approved pembrolizumab, an immune checkpoint inhibitor, for treating patients with resectable locally advanced head and neck squamous cell carcinoma.
- This FDA approval is based on findings from the KEYNOTE-689 study, a phase 3 clinical trial.
- The new regimen marks a critically important shift in head and neck cancer care, offering suitable patients the option to receive pembrolizumab before surgery for resectable locally advanced...
The FDA has approved pembrolizumab, a groundbreaking immune checkpoint inhibitor, for treating resectable head and neck cancer in patients exhibiting PD-L1 expression. This critically important advancement, based on KEYNOTE-689 trial results, offers a new approach to cancer care.Patients receiving pembrolizumab before, during, and after surgery showed improved event-free survival. This marks a major shift, potentially transforming how head and neck cancer is managed. The findings, presented at the 2025 AACR Annual Meeting, highlight pembrolizumab’s efficacy and safety. News Directory 3 is following this story closely, eager to keep you informed about the latest medical breakthroughs. Discover what’s next in this evolving field of oncology.
FDA Approves Pembrolizumab for Resectable Head and Neck Cancer with PD-L1 Expression
Teh U.S.Food and Drug Governance (FDA) has approved pembrolizumab, an immune checkpoint inhibitor, for treating patients with resectable locally advanced head and neck squamous cell carcinoma. The approval applies to patients whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1], as resolute by an FDA-approved test.
This FDA approval is based on findings from the KEYNOTE-689 study, a phase 3 clinical trial. The study, led by investigators at Dana-Farber Brigham Cancer Center and washington University school of Medicine in St. Louis, found that patients receiving pembrolizumab before, during, and after standard surgery experienced longer event-free survival and higher rates of tumor shrinkage prior to surgery.
The new regimen marks a critically important shift in head and neck cancer care, offering suitable patients the option to receive pembrolizumab before surgery for resectable locally advanced head and neck cancer.
Dr. Ravindra Uppaluri, the study’s principal investigator and director of Head and neck Surgical Oncology at Dana-Farber and Brigham and Women’s Hospital, said this represents the first advance in this field in over two decades.
Dr. Robert Haddad, chief of the Division of Head and Neck Oncology at Dana-Farber, noted that this is the first approval of a checkpoint inhibitor in the curative, perioperative setting, marking a massive paradigm shift in how surgically treated head and neck cancer is managed.
the KEYNOTE-689 trial involved 714 patients with newly diagnosed stage 3 or 4A head and neck squamous cell cancer. Participants were randomized to receive either pembrolizumab before, during, and after standard of care, or standard of care alone. Investigators also assessed PD-L1 levels in tumors to determine if higher scores affected treatment response.
Results showed that patients receiving pembrolizumab had longer event-free survival, with a median of 51.8 months compared to 30.4 months without pembrolizumab, after a median follow-up of 38.3 months. The team also observed significantly higher rates of major pathologic response, indicating ample immune-mediated tumor destruction.
The treatment was found to be safe, with no new side effects observed. Patients receiving pembrolizumab underwent surgery in a timely manner, without delays caused by immunotherapy-related side effects.
The data was previously presented at the 2025 American Association of Cancer research (AACR) Annual Meeting.