GSK says EMA validates cancer drug submission
By Frank Prenesti
Date: Tuesday 25 Apr 2023
(Sharecast News) - GSK said the European Medicines Agency had validated the its submission for a potential new indication of its treatment for a type of gynaecological cancer known as mismatch repair deficient primary advanced or recurrent endometrial cancer.
The move comes after the first part of a phase 3 trial of its Jemperli (dostarlimab) treatment in combination with chemotherapy for adult patients.
As a result, the EMA's Committee for Medicinal Products for Human Use will begin the formal review process to make a recommendation to the European Commission regarding marketing authorisation for the potential new indication.
Reporting by Frank Prenesti for Sharecast.com
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