FDA grants accelerated approval for Jemperli in endometrial cancer – GSK

The FDA has granted accelerated approval to Jemperli (dostarlimab), from GlaxoSmithKline, 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 (which contain abnormalities that affect the proper repair of DNA inside the cell), as determined by an FDA-approved test.

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 (disappearance of tumor) or a partial response (shrinkage of tumor) 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).