EMA validates filing of Jemperli + chemo for dMMR/MSI-H endometrial cancer
GSK announced that the European Medicines Agency (EMA) validated the Company’s Type II Variation for a potential new indication for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with a type of gynaecological cancer known as mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer
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.
The regulatory submission is based on the interim results of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial. The trial met its primary endpoint of investigator-assessed progression-free survival (PFS), showing a statistically significant and clinically meaningful benefit versus placebo plus chemotherapy in patients treated with dostarlimab plus carboplatin-paclitaxel in the dMMR/MSI-H population. In addition, the safety and tolerability profile of dostarlimab in combination with carboplatin-paclitaxel was generally consistent with the known safety profiles of the individual agents.
The results were presented on 27 March 2023 at a European Society for Medical Oncology Virtual Plenary and the Society of Gynecologic Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine.
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