GSK : Jemperli Granted Priority Review By FDA For Expanded Use In Endometrial Cancer Treatment

(RTTNews) - The US Food and Drug Administration accepted the supplemental Biologics License Application or sBLA for Jemperli (dostarlimab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) to expand treatment to all adult patients with primary advanced or recurrent endometrial cancer. It would include patients with mismatch repair proficient or MMRp/microsatellite stable or MSS tumours, GSK plc (GSK, GSK.L) said in a statement on Wednesday.

Currently, Jemperli is FDA-approved in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is either mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).

The FDA granted Priority Review for this application and assigned a Prescription Drug User Fee Act action date of 23 August 2024.

Jemperli?was discovered by AnaptysBio and licensed to TESARO, under a collaboration and exclusive license agreement signed in March 2014. Under the agreement, GSK is responsible for the ongoing research, development, commercialisation, and manufacturing of Jemperli, and cobolimab (GSK4069889), a TIM-3 antagonist.

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