The U.S. Food and Drug Administration (FDA) has acknowledged a supplementary Biologics License Application (sBLA) for Jemperli (dostarlimab). This is in collaboration with the standard-of-care chemotherapy drugs, carboplatin and paclitaxel. The aim is to broaden the treatment options for all adult patients experiencing primary advanced or recurrent endometrial cancer. This would extend to patients with mismatch repair proficient (MMRp) or microsatellite stable (MSS) tumours. This information has been confirmed by the pharmaceutical company, GlaxoSmithKline (GSK).
At present, the FDA has approved the use of Jemperli used in conjunction with carboplatin and paclitaxel. This protocol is followed by using Jemperli individually to treat adult patients with primary advanced or recurrent endometrial cancer. This applies to patients whose cancer is either deficient in mismatch repair (dMMR) or has high microsatellite instability (MSI-H), as confirmed by an FDA-approved test.
The FDA has prioritized the review of this application and has set a completion date of August 23, 2024, under the Prescription Drug User Fee Act.
Jemperli was originally discovered by AnaptysBio before being licensed to TESARO. This was part of an exclusive licence agreement made in March 2014. As part of this deal, GSK is responsible for the continuous research, development, commercialization and production of Jemperli, as well as cobolimab (GSK4069889), an antagonist of TIM-3.
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