GSK plc (GSK) Monday said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the approval of Jemperli in combination with chemotherapy for the treatment of patients with primary advanced or recurrent endometrial cancer.
A decision from the regulator is expected in the first quarter of 2025.
The application for expanded approval of Jemperli was based on results from Part 1 of the RUBY phase III trial, in which the study had met its primary goals of progression-free survival (PFS) and overall survival (OS).
In August this year, the drug had got expanded approval from the FDA for the treatment of primary advanced or recurrent endometrial cancer.
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