(Sharecast News) - 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.
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
Glaxosmithkline (GSK)
