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Jemperli Receives Accelerated Approval to Treat Solid Tumors
August 17, 2021 – The U.S. FDA has approved a new indication for Jemperli® (dostarlimab-gxly), manufactured by GlaxoSmithKline. The drug is now indicated to treat adults who have mismatch repair- deficient (dMMR) recurrent or advanced solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. Because Jemperli received accelerated approval for this use, continued approval of the indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Mismatch repair, or MMR, is a process that helps recognize and repair errors in the body’s DNA. MMR deficiency, when this process doesn’t work properly, can contribute to the rise and proliferation of cancerous tumors.
In a clinical trial, Jemperli delivered an objective response rate of 41.6% for all dMMR solid tumors, with a complete response rate of 9.1% and a partial response rate of 32.5%. The median duration of response was 34.7 months. Most (95.4%) patients who responded to treatment had a response lasting at least six months.
Recommended dosing is 500mg every three weeks for the first four doses. Starting three weeks after the fourth dose, patients are given 1,000mg once every six weeks. Jemperli is administered via 30-minute intravenous infusion, with treatment continuing until disease progression or unacceptable toxicity occur.
First FDA approved in April 2021, Jemperli is also indicated to treat recurrent or advanced dMMR tumors in adults who have endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.