Merck, known as MSD outside the United States and Canada, announced that the US 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.
Cervical cancer forms in the cells lining the cervix, or the lower part of the uterus. In 2017, approximately 12,820 cases of cervical cancer were diagnosed in the US. The five-year survival rate of women with stage IV disease is an estimated 15-16 percent. Any woman can develop cervical cancer, but it is more commonly diagnosed in women between the ages of 35 and 44. While screenings and vaccinations have resulted in declining cervical cancer rates, the disease continues to affect women in the US and throughout the world.
Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
Merck has the industry’s largest immuno-oncology clinical research program, which currently involves more than 700 trials studying Keytruda across a wide variety of cancers and treatment settings. The Keytruda clinical program seeks to understand the role of Keytruda across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with Keytruda, including exploring several different biomarkers.