FDA Approves Keytruda as First Immune Checkpoint Inhibitor for Resectable Locally Advanced Head and Neck Cancer
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.
The FDA approval is based on data from the pivotal KEYNOTE-689 study, a randomized, open-label phase 3 clinical trial in which patients who received pembrolizumab before, during and after standard-of-care surgery had longer event-free survival without the cancer coming back and higher rates of substantial tumor shrinkage prior to surgery. The study was led by investigators from Dana-Farber Brigham Cancer Center and Washington University School of Medicine in St. Louis.
This new regimen represents a substantial change in workflow for head and neck cancer care, offering appropriate patients the option of receiving pembrolizumab before surgery for resectable locally advanced head and neck cancer.
“These findings represent a truly exciting time for our patients, as it is the first advance in this field in over two decades,” said Dr. Ravindra Uppaluri, the study’s overall principal investigator, director of Head and Neck Surgical Oncology at Dana-Farber and Brigham and Women’s Hospital, and Brigham and Women’s Hospital Endowed Chair in Otolaryngology.
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