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RAHWAY, N.J. – Merck & Co., Inc., known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) for KEYTRUDA, the company’s anti-PD-1 therapy. The sBLA seeks approval for KEYTRUDA in combination with chemotherapy for the treatment of patients with primary advanced or recurrent endometrial carcinoma, followed by KEYTRUDA as a single agent. The FDA has set a target action date of June 21, 2024.
The sBLA is supported by data from the Phase 3 NRG-GY018 trial, which showed that KEYTRUDA plus chemotherapy significantly improved progression-free survival compared to chemotherapy alone in patients with endometrial carcinoma, regardless of mismatch repair status. The trial results indicated a 46% reduction in the risk of disease progression or death in patients with mismatch repair proficient tumors and a 70% reduction in patients with mismatch repair deficient tumors.
Dr. Ramez Eskander, the principal investigator of the study, emphasized the potential of KEYTRUDA to address a significant unmet need for patients with advanced stage or recurrent endometrial cancer, where frontline treatment options are limited.
If approved, KEYTRUDA would be the first immunotherapy indicated for the frontline treatment of advanced endometrial cancer irrespective of mismatch repair status. Dr. Gursel Aktan, vice president at Merck Research Laboratories, highlighted the company’s commitment to working with the FDA to make KEYTRUDA available to patients in need.
The trial was sponsored by the U.S. National Cancer Institute, designed and led by NRG Oncology with funding from the NCI and participation from all National Clinical Trials Network Groups. Merck provided funding and support through a Cooperative Research and Development Agreement with the NCI.
Additionally, the review is part of Project Orbis, an initiative of the FDA Oncology Center of Excellence, which allows for concurrent submission and review of oncology drugs among international partners. Health authorities in Israel, Canada, Australia, Singapore, and Brazil are also reviewing the application.
In the U.S., KEYTRUDA already has two approved indications for endometrial cancer, both as a combination with LENVIMA and as a single agent for certain patients with advanced endometrial carcinoma. This news is based on a press release statement.
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