EU recommends expanding use of GSK endometrial cancer drug

GSK said the European Union's Committee for Medicinal Products for Human Use has recommended expanding approval of Jemperli in combination with chemotherapy for treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.

The CHMP opinion is one of the final steps prior to a marketing authorisation decision by the European Commission, with an approval decision expected in the first quarter of 2025, the company said on Monday.

It’s application to expand the use of Jemperli – also known as dostarlimab - is based on results from Part 1 of the RUBY phase III trial, which met its dual primary endpoints of investigator-assessed progression-free survival and overall survival, demonstrating a “statistically significant and clinically meaningful benefit in the full population of patients treated”.

“Dostarlimab plus chemotherapy is the only immuno-oncology-based regimen to show a statistically significant overall survival benefit in this patient population.”

Endometrial cancer is found in the inner lining of the uterus and is the most common gynaecologic cancer in developed countries with an estimated 1.6 million people living with active disease at any stage and 417,000 new cases reported each year worldwide.

Incidence rates are expected to rise by approximately 40% between 2020 and 2040.

Reporting by Frank Prenesti for Sharecast.com