The FDA will give Keytruda (pembrolizumab) priority review in head and neck cell carcinoma.
Keytruda (pembrolizumab) is a humanized antibody that acts as a programmed death-ligand (PD-L1) inhibitor. It has already been approved for intravenous infusion to treat inoperable or metastatic melanoma, metastatic non-small cell lung cancer (NSCLC) in certain situations, as a second-line treatment for head and neck squamous cell carcinoma (HNSCC) after platinum-based chemotherapy and for the treatment of adult and pediatric patients with refractory classic Hodgkin's lymphoma.
Now the U.S. Food and Drug Administration (FDA) has indicated that it will give priority review to a frontline use of Keytruda in head and neck cell carcinoma. The review will be based on results of Merck’s KEYNOTE-048 study, in which patients with high levels of PD-L1 were observed to experience a 39% improvement in overall survival compared with standard care, while patients with lower levels saw a 22% improvement in overall survival.
The review date established under PDUFA is June 10, 2019, but since the FDA has been completing review of oncology drugs fairly quickly, it is possible that Merck will receive a decision even sooner.