Merck announced that the U.S. Food and Drug Administration (FDA) has accepted a new supplemental Biologics License Application (sBLA) and granted Priority Review for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy.
The application is seeking approval for KEYTRUDA as a treatment for patients with advanced cervical cancer with disease progression on or after chemotherapy. This is 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 KEYTRUDA. The FDA has set a PDUFA, or target action, date of June 28, 2018.
“Advanced cervical cancer is an illness with a poor prognosis and a high unmet medical need. 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,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.
The application, which is seeking accelerated approval for this new indication, is based in part on data from the phase 2 KEYNOTE-158 trial. KEYNOTE-158 is an ongoing global, open-label, non-randomized, multi-cohort, multi-center study evaluating KEYTRUDA in patients with multiple types of advanced solid tumors – including cervical cancer – that have progressed on standard of care therapy.
Merck is executing an extensive clinical development program in a broad range of cancers that affect women. To date, the program includes numerous studies evaluating KEYTRUDA (pembrolizumab) as monotherapy or in combination with other anti-cancer treatments across various types of breast and gynecological cancers.
Filed Under: Drug Discovery