Jemperli Receives Accelerated Approval for Endometrial Cancer

Jemperli Receives Accelerated Approval for Endometrial Cancer

April 22, 2021 – The U.S. FDA has granted accelerated approval to Jemperli® (dostarlimab-gxly), manufactured by GlaxoSmithKline, to treat mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, in adults whose disease has progressed on or following prior treatment with a platinum-containing regimen. Continued approval for the indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

An estimated 60,000 women in the United States are diagnosed with endometrial cancer annually. About a quarter of women with endometrial cancer also test positive for dMMR, which is associated with an increased risk of disease recurrence. Roughly one in four women with endometrial cancer will experience a recurrence or be diagnosed with advanced disease, and treatment options are limited when the disease returns after platinum-containing chemotherapy.

In a clinical study, Jemperli delivered an overall response rate of 42.3%, with a six-month or greater duration of response in 93.3% of patients who responded to treatment. Recommended dosing is 500mg administered via 30-minute intravenous infusion once every three weeks for the first four doses. Subsequent dosing, beginning three weeks after Dose 4, is 1,000mg every six weeks until disease progression or unacceptable toxicity occur.

Jemperli has launched at a wholesale acquisition cost (WAC) of $10,369.38 per 500mg vial.