FDA Accepts Pembrolizumab sBLA for Treatment of Advanced Cervical Cancer
On March 13, 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 pembrolizumab (Keytruda), the company’s anti–programmed cell death protein 1 (PD-1) therapy. The application is seeking approval for pembrolizumab 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. The FDA has set a Prescription Drug User Fee Act (PDUFA) 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 [pembrolizumab] to previously treated patients with advanced cervical cancer,” said Roger Dansey, MD, Senior Vice President and Therapeutic Area Head, Oncology Late-Stage Development, Merck Research Laboratories.
KEYNOTE-158
The application, which is seeking accelerated approval for this new indication, is based in part on data from the phase II KEYNOTE-158 trial. KEYNOTE-158 is an ongoing global, open-label, nonrandomized, multicohort, multicenter study evaluating pembrolizumab 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 pembrolizumab as monotherapy or in combination with other anticancer treatments across various types of breast and gynecologic cancers.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
