FDA Grants Accelerated Approval to Jemperli for Endometrial Cancer

The Food and Drug Administration (FDA) on Thursday granted accelerated approval to Jemperli (dostarlimab) for the treatment of patients with recurrent or advanced endometrial cancer whose disease has progressed on, or following, prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic biomarker known as deficient mismatch repair (dMMR).

“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 Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in a news release from the agency. “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.”

Endometrial cancer is the most common gynecologic cancer in the United States and, although 75% of cases are diagnosed at an early stage and are usually treatable with surgery, some cases require further treatment. Women with advanced or recurrent disease have limited treatment options following initial standard treatment with platinum-containing chemotherapy.

Approximately 25% to 30% of patients with advanced disease have tumors that express dMMR.

The FDA based its decision on data from a single-arm, multi-cohort trial of 71 patients with dMMR recurrent or advanced endometrial cancer. Complete or partial response to Jemperli treatment was 42.3%. The response lasted for six months or more in 93% of respondents.

Patients treated with Jemperli commonly experienced fatigue, nausea, diarrhea, anemia (low blood cell counts) and constipation. The FDA noted in its release that treatment with Jemperli can cause serious conditions such as inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis).

Women who are pregnant or breastfeeding, according to the FDA, should not take Jemperli as it may harm the fetus or newborn child.

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