FDA Approves Dostarlimab for dMMR Advanced Endometrial Cancer

The FDA approved dostarlimab (Jemperli) for the treatment of patients with recurrent or advanced endometrial cancer that progressed on or after platinum-containing chemotherapy and whose cancer is DNA mismatch repair deficient (dMMR), as determined by an FDA-approved test.

The PD-1/PD-L1 inhibitor was approved based on findings from a single-arm, multi-cohort clinical trial, which showed that 42.3% of the 71 patients with dMMR advanced endometrial cancer had a complete or partial response. In the majority of patients (93%), the response lasted 6 months or more.

“Today’s approval of Jemperli is evidence of the FDA’s progress in applying precision medicine to expand treatment options for patients with cancer,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a press release. “This immunotherapy was specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response in this unmet medical need population.”

Common adverse events (AEs) for the drug include fatigue, nausea, diarrhea, anemia, and constipation. Since the drug activates the immune system to fight cancer, serious immune-related AEs, including: pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis.

If a patient experiences a severe or life-threatening infusion reaction, they should stop taking dostarlimab.

Reference:

FDA. FDA Approves Immunotherapy for Endometiral Cancer With Specific Biomarker. April 22, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-immunotherapy-endometrial-cancer-specific-biomarker. Accessed April 22, 2021