GSK’s Jemperli accepted for review by EMA for endometrial cancer treatment
Betsy Goodfellow | June 24, 2024 | News story | Medical Communications | EMA, GSK, Jemperli, Oncology, endometrial cancer
GSK has announced that the European Medicines Agency (EMA) has accepted the application to expand the use of Jemperli (dostarlimab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) for the treatment of adult patients with primary advanced or recurrent endometrial cancer.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected to begin the formal review process in order to make a recommendation to the European Commission (EC) with approval expected during the first half of 2025.
Jemperli is currently approved in the EU in combination with chemotherapy for the treatment of ‘adult patients who are candidates for systemic therapy with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H)’, according to the company’s press release.
The press release continues, explain that ‘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 (MMRp)/microsatellite stable (MSS) tumours where currently there are no approved frontline immuno-therapy-based treatments in the EU’.
This application follows results from part 1 of the RUBY phase 3 trial, which met its primary endpoints of investigator-assessed progression-free survival (PFS) and overall survival (OS). The results were presented at the Gynecologic Oncology Annual Meeting on Women’s Cancer held on 16 March 2024, as well as being published in the Annals of Oncology on 9 June 2024.
Betsy Goodfellow
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