A New Rx for Endometrial Cancer

The US Food and Drug Administration (FDA) has approved a new immunotherapy treatment for a certain type of endometrial cancer.

The FDA approved Jemperli (dostarlimab) to treat women who have recurrent or advanced endometrial cancer that has not responded to chemotherapy that contains platinum and has a genetic abnormality that prevents the proper repair of DNA inside the cell.

This genetic abnormality is called dMRR. Before women can receive this newly approved treatment, an FDA-approved test must show that they have dMRR. The FDA estimated that between 25 and 30 percent of women with advanced endometrial cancer have dMRR tumors.

“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 Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the FDA's Office of Oncologic Diseases, 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.”

Most endometrial cancer in the United States is diagnosed at an early stage and is treatable through surgery, the FDA noted. But women who have advanced endometrial cancer have had few treatment options. The approval of Jemperli adds another option for women who have advanced dMRR endometrial cancer.

Jemperli is an immunotherapy. That means it works to boost the body's ability to fight against cancer cells.

In a trial of patients with advanced or recurrent dMRR endometrial cancer, 42.3 percent of the 71 women who received Jemperli saw their cancer tumor completely disappear or shrink significantly. This response lasted for six months or longer for 93 percent of the patients.

Common side effects of Jemperli included anemia, nausea, diarrhea, constipation and tiredness. Jemperli also poses a risk of severe side effects called immune-mediated reactions, according to the FDA. These include inflammation of healthy organs like the kidneys, lungs, liver, colon and endocrine glands.

Pregnant or breastfeeding women and those who experience life-threatening infusion-related reactions should not take this medication, the FDA said.

The FDA approved Jemperli for GlaxoSmithKline.

Talk to your doctor about the treatments available for your condition.