India Pharma Outlook Team | Tuesday, 21 January 2025
GSK plc announced that the European Commission has authorized Jemperli (dostarlimab) in conjunction with chemotherapy (carboplatin and paclitaxel) as a first-line therapy for adult patients with primary advanced or recurrent endometrial cancer eligible for systemic treatment. This approval expands the former indication for Jemperli combined with chemotherapy in the European Union (EU) to encompass patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors, accounting for about 75% of individuals diagnosed with endometrial cancer and facing restricted treatment alternatives.
Hesham Abdullah, senior vice president, global head oncology, R&D, GSK, said: “For the first time, all patients with primary advanced or recurrent endometrial cancer in the EU have an approved immuno-oncology-based treatment that has shown a statistically significant and clinically meaningful overall survival benefit. We’re proud Jemperli continues to redefine the treatment landscape for patients.”
Dr Mansoor Raza Mirza, chief oncologist, Copenhagen University Hospital, Denmark, and RUBY principal investigator said: “Clinicians have been waiting for years for an immuno-oncology-based option that can meaningfully improve overall survival outcomes for patients with MMRp/MSS primary advanced or recurrent endometrial cancer. The expanded approval represents a significant advance that delivers on this hope, now for patients with both dMMR/MSI-H and MMRp/MSS tumours.”