LONDON (dpa-AFX) - 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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