LONDON (dpa-AFX) - 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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