|Other names||TSR-042, WBP-285, dostarlimab-gxly|
|Main uses||Mismatch repair deficient (dMMR) recurrent or advanced cancer|
|Side effects||Tiredness, nausea, diarrhea, anemia|
|Chemical and physical data|
|Molar mass||144325.73 g·mol−1|
Dostarlimab, sold under the brand name Jemperli, is a medication used to treat certain solid tumors such as endometrial cancer. Specifically it is used for mismatch repair deficient (dMMR) recurrent or advanced cancer. Benefits were seen in 44% of cases. It is given by gradual injection into a vein.
Common side effects include tiredness, nausea, diarrhea, and anemia. Other side effects may include joint pain, itching, rash, fever, and low thyroid. Severe side effect may include pneumonitis, colitis and hepatitis due to immune dysfunction. Use during pregnancy may harm the baby. It is a monoclonal antibody which blocks programmed death receptor-1 (PD-1), thus allowing the immune system to kill cancer cells.
Dostarlimab was approved for medical use in the United States and Europe in 2021. In the United States it costs about 11,400 USD per 500 mg as of 2022. In the United Kingdom this amount costs about £5,900.
Dostarlimab is used to treat adults with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, that has progressed on or following prior treatment with a platinum-containing regimen.
In 2021, the US Food and Drug Administration (FDA) granted accelerated approval to dostarlimab for adults with 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.
The dose is 500 mg once every 3 weeks for the first 4 doses and then 1,000 mg every 6 weeks.
Dostarlimab is a PD-1 inhibitor. As of 2020[update], it was undergoing Phase I/II and Phase III clinical trials. In 2020, the manufacturer, Tesaro, announced preliminary successful results from the Phase I/II GARNET study.
In April 2021, dostarlimab was approved for the treatment of recurrent or advanced endometrial cancer with deficient mismatch repair (dMMR), which are genetic abnormalities that disrupt DNA repair.
In April 2021, the Food and Drug Administration granted accelerated approval to dostarlimab-gxly (Jemperli, GlaxoSmithKline). Efficacy was evaluated based on cohort (A1) in GARNET Trial (NCT02715284), a multicenter, multicohort, open-label trial in participants with advanced solid tumors.
A 2022 early clinical study of dostarlimab reported a 100% remission rate in 14 patients who had mismatch repair deficiency in their rectal cancer, a type of genetic mutation that affects only 5-10% of cases.
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On 25 February 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product, intended for the treatment of certain types of recurrent or advanced endometrial cancer. The applicant for this medicinal product is GlaxoSmithKline (Ireland) Limited. Dostarlimab was approved for medical use in the European Union in April 2021.
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