GSK's Jemperli with chemotherapy accepted for priority review by FDA

(Alliance News) - GSK PLC on Wednesday said that the US Food & Drug Administration has accepted a supplemental biologics licence application for Jemperli, when used in combination with chemotherapy.

According to the Brentford, London-based pharmaceutical company, this would expand treatment to all adult patients with primary advanced or recurrent endometrial cancer, and would include patients with mismatch repair proficient or microsatellite stable tumours.

Jemperli, otherwise known as dostarlimab, has already been approved by the FDA in combination with carboplatin and paclitaxel.

The supplemental biologics licence application, GSK explained, is based on results from part one of the RUBY Phase III trial. The trial, the firm added, demonstrated "a statistically significant and clinically meaningful benefit in the overall population of patients treated with dostarlimab plus carboplatin-paclitaxel versus chemotherapy alone".

Jemperli has been given August 23 as a prescription drug user fee act action date for the FDA decision.

GSK shares were trading 0.3% higher at 1,655.50 pence each in London on Wednesday morning.

By Holly Beveridge, Alliance News reporter

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