EMA validates marketing authorization application for dostarlimab combination chemotherapy for advanced or recurrent primary endometrial cancer dMMR/MSI-H

The application is based on data from the Phase III RUBY study, which met its primary endpoint of investigator-assessed progression-free survival (PFS), showing a statistically and clinically significant benefit over placebo plus chemotherapy in patients treated with dostarlimab plus carboplatin-paclitaxel in the dMMR/MSI-H population.

26 APR –

The European Medicines Agency (EMA) has validated the type II variation for a potential new indication for i have deliveredlimb, in combination with chemotherapy, for the treatment of adult patients with advanced or recurrent primary endometrial cancer with mismatch repair deficiency (dMMR)/high microsatellite instability level (MSI-H). As a result, EMA’s Committee for Medicinal Products for Human Use will initiate the formal review process in order to make a recommendation to the European Commission regarding the marketing authorization of this potential new indication. This was announced by GSK.

Application is based on interim results from the Phase III RUBY/ENGOT-EN6/GOG3031/NSGO study. The study met its primary endpoint of investigator-assessed progression-free survival (PFS), showing a statistically and clinically significant benefit over placebo plus chemotherapy in patients treated with dostarlimab plus carboplatin-paclitaxel in the dMMR/MSI-H population. Additionally, 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 findings were presented on March 27, 2023 at the virtual plenary meeting of the European Society of Medical Oncology and the Annual Meeting of the Gynecological Oncology Society and simultaneously published in the New England Journal of Medicine.

“New treatment options are needed for patients with advanced or recurrent primary endometrial cancer,” said Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK. “With this submission, we are accelerating the submission of a potential new indication for dostarlimab in the patient population that demonstrated the strongest therapeutic effect in the Phase III RUBY study.These patients currently face significant unmet medical needs, and this combination could change the treatment paradigm for this condition.The Phase III RUBY study continues to follow the patients for the dual primary endpoint of overall survival in the intent-to-treat population”. The company estimates that approval in the United States will occur by June.

April 26, 2023
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