The FDA granted a priority review to the supplemental biologics license application for pembrolizumab (Keytruda) for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), according to Merck, the drug’s manufacturer.
“Head and neck cancer remains a challenging and devastating disease, and newly diagnosed patients are in need of improved treatment options,” said Jonathan Cheng, MD, vice president of clinical research at Merck Research Laboratories, said in a press release
. “Merck continues to make meaningful advances in the treatment of head and neck cancer, and we look forward to working with the FDA to bring these important new options to patients in the first-line setting.”
The application – which included pembrolizumab as a monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy – was based in part on data from the pivotal, randomized, open-label phase III KEYNOTE-048 trial, designed to evaluate both pembrolizumab regimens compared with Erbitux (cetuximab) as first-line treatment in 882 patients with recurrent or metastatic HSNCC.
Overall (OS) and progression-free survival (PFS) served as the co-primary endpoints, while secondary endpoints included PFS at 6 and 12 months, objective response rate (ORR) and time to deterioration in Quality of Life Global Health Status/Quality of Life Scales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire and Safety.
The anti-PD-1 immunotherapy agent
demonstrated a significant improvement in overall survival compared with the standard of care, as monotherapy in patients whose tumors expressed PD-L1 with CPS≥20 and CPS≥1, and in combination with chemotherapy in the total patient population.
The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 10, 2019.