EMA validates marketing authorisation application for Jemperli
GSK has announced that the European Medicines Agency (EMA) has validated the company’s Type II Variation for a new indication for Jemperli (dostarlimab) alongside chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected to soon begin the formal review process and make its recommendation to the European Commission (EC) surrounding the marketing authorisation for the drug’s new indication.
