FDA grants fast-track approval to Jemperli for endometrial cancer

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

“Today’s approval of Jemperli is proof of the FDA’s progress in applying precision medicine to expand treatment options for cancer patients,” said Dr. Richard Pazdur, director of the FDA’s Center of Excellence in Oncology and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, in an agency press release. “This immunotherapy has been specifically studied to target dMMR endometrial cancer and takes advantage of the scientific knowledge surrounding the mechanism of the immunotherapy response in this population of unmet medical needs.

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

About 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 recurrent or advanced endometrial cancer dMMR. The complete or partial response to treatment with Jemperli was 42.3%. The response lasted six months or more in 93% of respondents.

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

Pregnant or breastfeeding women, according to the FDA, should not take Jemperli as it could harm the fetus or newborn.

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