FDA accepts sBLA for Keytruda (pembrolizumab) + chemotherapy to treat primary advanced or recurrent endometrial carcinoma
Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel), followed by Keytruda as a single agent for the treatment of patients with primary advanced or recurrent endometrial carcinoma
The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 21, 2024.
The sBLA is based on data from the Phase III NRG-GY018 trial. Results from the study, presented at the 2023 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer and simultaneously published in the New England Journal of Medicine, showed Keytruda plus chemotherapy reduced the risk of disease progression or death by 46% (HR=0.54 [95% CI, 0.41-0.71]; p<0.00001) in patients whose cancer was mismatch repair proficient (pmmr) and by 70% (hr="0.30" [95% ci, 0.19-0.48]; p><0.00001) in patients whose cancer was mismatch repair deficient (dmmr), compared to chemotherapy alone.
“Endometrial cancer is the most common type of gynecological cancer, and frontline treatment options are limited for patients with advanced stage or recurrent disease,” said Dr. Ramez Eskander, principal investigator and gynecologic oncologist, University of California San Diego, Moores Cancer Center. “The use of Keytruda in this setting has the potential to address a significant unmet need for these patients.”
“If approved, Keytruda would be the first immunotherapy indicated for the frontline treatment of advanced endometrial cancer regardless of mismatch repair status,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. “We are committed to working closely with the FDA to bring Keytruda to these patients who are in need of additional treatment options, and we thank our collaborators for their partnership on this study.”
This trial was sponsored by the U.S. National Cancer Institute (NCI), part of the National Institutes of Health. NRG Oncology designed and led the trial with funding from the NCI and participation from all the National Clinical Trials Network (NCTN) Groups. Merck provided funding and support through a Cooperative Research and Development Agreement (CRADA) between Merck and NCI.
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