Speakers from Touchstone Exploration, Shanta Gold, Savannah Resources and Kavango Resources feature in our Natural Resources webinar on May 25th. Please register here.

Less Ads, More Data, More Tools Register for FREE

GSK's Jemperli approved by US regulator for endometrial cancer

Thu, 22nd Apr 2021 21:06

(Alliance News) - GlaxoSmithKline PLC said Thursday the US Food & Drug Administration has approved Jemperli for for women with recurrent or advanced dMMR endometrial cancer.

Dostarlimab, the medical name for Jemperli, is indicated for the treatment of adult patients with mismatch repair deficient, dMMR, recurrent or advanced endometrial cancer, as determined by an FDA approved test, that have progressed on or following prior treatment with a platinum containing regimen, GSK noted.

It continued: "This indication is approved under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial."

The approval is based on the Garnet study, which GSK said is the largest dataset of anti-PD-1 monotherapy treatment of women with endometrial cancer.

Results from the study showed an overall response rate of 42%. Of those that responded, 93.3% demonstrated a duration of response of 6 months or more.

Hal Barron, chief scientific officer & President Research & Development at GSK, said: "Unfortunately, as many as 60,000 women are diagnosed with endometrial cancer in the US each year and these women currently have limited treatment options if their disease progresses on or after first-line therapy.

"Today's approval of dostarlimab by the FDA has the potential to transform the treatment landscape for these women and demonstrates our continued commitment to helping patients with gynaecologic cancers."

Shares in GlaxoSmithKline closed down 0.1% in London on Thursday at 1,346.40 pence each.

By Paul McGowan; paulmcgowan@alliancenews.com

Copyright 2021 Alliance News Limited. All Rights Reserved.

Related Shares

More News

UK dividends calendar - next 7 days

UK dividends calendar - next 7 days

13 May 21 16:07

BROKER RATINGS: Just Eat Takeaway and Aston Martin get upgrades

BROKER RATINGS: Just Eat Takeaway and Aston Martin get upgrades

12 May 21 09:34

LONDON BRIEFING: UDG Healthcare accepts GBP2.6 billion takeover offer

LONDON BRIEFING: UDG Healthcare accepts GBP2.6 billion takeover offer

12 May 21 08:11

Tuesday broker round-up

(Sharecast News) - Safestore: Liberum upgrades to buy with a target price of 1,060p.

11 May 21 13:31

Login to your account

Don't have an account? Click here to register.

Quickpicks are a member only feature

Login to your account

Don't have an account? Click here to register.