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GSK's Application for Jemperli's Expanded Indication Accepted by FDA for Priority Review
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GSK's Application for Jemperli's Expanded Indication Accepted by FDA for Priority Review
Apr 24, 2024 7:51 AM

10:38 AM EDT, 04/24/2024 (MT Newswires) -- GSK (GSK) said Wednesday that the US Food and Drug Administration granted priority review to its supplemental Biologics License Application for Jemperli in combination with chemotherapy to expand treatment to all adult patients with primary advanced or recurrent endometrial cancer.

The FDA has set an expected action date of Aug. 23, according to the company.

Jemperli, or dostarlimab, is approved in the US in combination with carboplatin and paclitaxel followed by Jemperli as a single agent to treat advanced or recurrent endometrial cancer that is either mismatch repair deficient or microsatellite instability-high, GSK said.

The company said Jemperli's supplemental application is backed by data from part one of phase 3 trial Ruby, GSK added.

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