GSK plc (GSK.L) Monday said the European Medicines Agency (EMA) has accepted its application to expand the use of Jemperli in combination with chemotherapy to treat all patients with primary advanced or recurrent endometrial cancer.
A decision from the regulator is expected in the first half of 2025.
The application is based on results from Part 1 of the Phase 3 study dubbed RUBY, in which primary endpoints of progression-free survival (PFS) and overall survival (OS) were met.
Currently, Jemperli in combination with chemotherapy is approved in the EU for the treatment of patients who are candidates for systemic therapy with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). If this new application is approved, dostarlimab would be expanded to all patients with primary advanced or recurrent endometrial cancer.
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May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.