GSK (GSK) said Monday that the European Commission has approved Jemperli in combination with chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.
This approval expands the previous indication for Jemperli plus chemotherapy in the European Union to include patients with mismatch repair proficient or microsatellite stable tumors, the company said.
The approval is based on results from the first part of the RUBY phase 3 trial, which showed a clinically meaningful and statistically significant overall survival benefit in the patients with a 31% reduction in risk of detah compared with chemotherapy alone.