GSK's endometrial cancer drug receives FDA approval
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Drugmaker GSK said on Wednesday that the US Food and Drug Administration has accepted a supplemental Biologics License Application for Jemperli, its drug aimed at treating endometrial cancer.
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GSK said the FDA had given the green light for Jemperli to be used in combination with standard-of-care chemotherapy in order to expand treatment to all adult patients with primary advanced or recurrent endometrial cancer, including patients with mismatch repair proficient/microsatellite stable tumours.
The approval was based on results from Part 1 of its RUBY phase III trial, which met its primary endpoints of investigator-assessed progression-free survival and overall survival, demonstrating a "statistically significant" and "clinically meaningful" benefit in the overall population of patients treated with dostarlimab plus carboplatin-paclitaxel versus chemotherapy alone.
"Dostarlimab plus chemotherapy is the only immuno-oncology-based therapy to show a statistically significant and clinically meaningful survival benefit in the overall patient population," noted GSK.
As of 0920 BST, GSK shares were up 0.35% at 1,656.50p.
Reporting by Iain Gilbert at Sharecast.com