GSK reports EMA accepts Jemperli plus chemo application for review

GSK plc announced the European Medicines Agency has accepted its application to expand the use of Jemperli in combination with standard-of-care chemotherapy to all adult patients with primary advanced or recurrent endometrial cancer. The EMA’s Committee for Medicinal Products for Human Use will begin the formal review process to make a recommendation to the European Commission, with approval expected in the first half of 2025. Currently, in the EU, Jemperli in combination with carboplatin and paclitaxel is approved for the treatment of adult patients who are candidates for systemic therapy with primary advanced or recurrent endometrial cancer that is mismatch repair deficient, or 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, regardless of their biomarker type, including those with mismatch repair proficient/microsatellite stable tumours where currently there are no approved frontline immuno-therapy-based treatments in the EU.