GSK's endometrial cancer drug receives FDA approval.


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
  • 15 May 2024 17:20:57
GSK

Source: Sharecast

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


Exchange: London Stock Exchange
Sell:
0.00
Buy:
0.00
Change: 17.67 ( 0.21 %)
Date:
Prices delayed by at least 15 minutes

Compare our accounts

Whether you're looking for a Share Dealing Account, Stocks and Shares ISA or a Self-Invested Personal Pension (SIPP), we've got an account to suit your needs..

Halifax is not responsible for the content and accuracy of the Markets News articles. We may not share the views of the author. Understand the risks, please remember the value of your investment can go down as well as up and you may not get back the full amount you invest. We don't provide advice so if you are in any doubt about buying and selling shares or making your own investment decisions we recommend you seek advice from a suitably qualified Financial Advisor. Past performance is not a guide to future performance.