FDA Approves Immunotherapy for Endometrial Cancer with Speci
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The U.S. Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR, as determined by an FDA-approved test.

Jemperli works by targeting the cellular pathway known as PD-1/PD-L1. Jemperli helps the body’s immune system in its fight against cancer cells by blocking this pathway. The safety and efficacy of Jemperli was studied in a single-arm, multi-cohort clinical trial. Of the 71 patients with dMMR recurrent or advanced endometrial cancer who received Jemperli in the trial, 42.3% had a complete response or a partial response to treatment with Jemperli. For 93% of responders, the response lasted for six months or more.

Common side effects of Jemperli include fatigue, nausea, diarrhea, anemia and constipation. Jemperli can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs such as the lungs (pneumonitis), colon (colitis), liver (hepatitis), endocrine glands (endocrinopathies) and kidneys (nephritis).

Patients who experience severe or life-threatening infusion-related reactions should stop taking Jemperli. Women who are pregnant or breastfeeding should not take Jemperli because it may cause harm to a developing fetus or newborn baby. The safety and effectiveness of Jemperli in pediatric patients are not known.

Jemperli received Priority Review and Breakthrough Therapy designation for this indication. Priority Review designation directs overall attention and resources to the evaluation of applications for drugs that would be significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions.

Source:
https://www.fda.gov/news-events/press-announcements/fda-approves-immunotherapy-endometrial-cancer-specific-biomarker
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