Merck: FDA Grants Priority Review To SBLA For KEYTRUDA Plus Chemotherapy In Endometrial Carcinoma

(RTTNews) - Drug major Merck & Co., Inc. (MRK) announced Tuesday that the U.S. Food and Drug Administration has accepted for priority review a new supplemental Biologics License Application or sBLA seeking approval for KEYTRUDA (pembrolizumab) in combination with standard of care chemotherapy (carboplatin and paclitaxel). This will be followed by KEYTRUDA as a single agent for the treatment of patients or primary advanced or recurrent Endometrial Carcinoma.

KEYTRUDA is Merck's anti-PD-1 therapy. 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 3 NRG-GY018 trial. Results from the study showed KEYTRUDA plus chemotherapy reduced the risk of disease progression or death by 46% in patients whose cancer was mismatch repair proficient or pMMR and by 70% in patients whose cancer was mismatch repair deficient or dMMR, compared to chemotherapy alone.

Endometrial cancer is the most common type of gynecological cancer. Its frontline treatment options are limited for patients with advanced stage or recurrent disease.

Gursel Aktan, vice president, global clinical development, Merck Research Laboratories, said, "If approved, KEYTRUDA would be the first immunotherapy indicated for the frontline treatment of advanced endometrial cancer regardless of mismatch repair status. 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, part of the National Institutes of Health.

In the U.S., KEYTRUDA has two approved indications in endometrial cancer.

For More Such Health News, visit rttnews.com