Last checked at 
(Alliance News) - GSK PLC on Monday said it won EU backing for its Jemperli drug in tandem with chemotherapy to treat a form of endometrial cancer.
The Brentford, West London-based pharmaceutical maker received marketing authorisation from the European Commission, making the combination the first and only frontline immuno-oncology treatment for adults with mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer. Endometrial cancer begins in the lining of the uterus.
"People living with this type of endometrial cancer typically experience disease progression and poor-long term outcomes with current standard of care. With this approval, we can expand the number of patients who can potentially benefit from treatment with Jemperli in Europe, including patients who are earlier in their journey," Hesham Abdullah, GSK's global head of oncology research & development said.
In October, GSK said Jemperli met the endpoint of overall survival in phase III Ruby trial on adult patients with primary advanced or recurrent endometrial cancer. Jemperli, combined with standard-of-care chemotherapy, followed by dostarlimab, demonstrated a "statistically significant and clinically meaningful benefit" to the patients in the trial.
Mansoor Mirza, chief oncologist at Copenhagen University hospital, and Ruby's principal investigator, said: "Today's European Commission approval is welcomed news as I believe it will define a new standard of care for certain patients with advanced or recurrent endometrial cancer in the EU. The results from the RUBY trial, which led to this approval, underscore the practice-changing potential of dostarlimab for these patients."
GSK shares were down 0.1% at 1,432.40 pence each on Monday morning in London.
By Tom Budszus, Alliance News slot editor
Comments and questions to newsroom@alliancenews.com
Copyright 2023 Alliance News Ltd. All Rights Reserved.
