The FDA has accepted a new supplemental Biologics License Application and granted Priority Review for Merck's pembrolizumab (Keytruda) for the treatment of advanced cervical cancer, marking the first filing acceptance for an anti–PD-1 therapy in cervical cancer.
The FDA has accepted a new supplemental Biologics License Application and granted Priority Review for pembrolizumab (Keytruda) for the treatment of advanced cervical cancer, announced Merck in a press release.
According to Merck, this marks the first filing acceptance and Priority Review granted for an anti—PD-1 therapy in cervical cancer and the 14th regulatory submission accepted by the FDA for pembrolizumab.
“Advanced cervical cancer is an illness with a poor prognosis and a high unmet medical need,” said Roger Dansey, MD, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories, in a statement. “We look forward to working with the FDA on the review of this application to help bring Keytruda to previously-treated patients with advanced cervical cancer.”
The application is seeking approval for pembrolizumab as treatment for patients with advanced cervical cancer with disease progression on or after chemotherapy and is based in part on data from the phase 2 KEYNOTE-158 trial. The ongoing global, open-label, non-randomized, multi-cohort, multi-center trial is evaluating pembrolizumab in patients with multiple types of solid tumors, including cervical cancer.
Pembrolizumab currently has indications for certain types of melanoma, non—small-cell lung cancer, head and neck cancer, classical Hodgkin lymphoma, urothelial cancer, microsatellite instability-high cancer, and gastric cancer.
Study findings presented at ASCO’s 2018 Genitourinary Cancers Symposium last month showed that there is greater overall survival benefit with recurrent urothelial cancer being treated with pembrolizumab versus chemotherapy. According to Joaquim Bellmunt, MD, PhD, of the Dana Farber Institute, this is the first immunotherapy to demonstrate superior survival over chemotherapy in patients with advanced urothelial carcinoma after failure of platinum-based therapy.
In January, Merck announced that the FDA had granted a Breakthrough Therapy Designation for lenvatinib and pembrolizumab as combination therapy for advanced and/or metastatic renal cell carcinoma (RCC) based on results from the RCC cohort in Study 111, which evaluated the safety and efficacy of the combination in selected solid tumors.