FDA Approval Alert: The Need-to-Know | Dostarlimab/Chemotherapy in Advanced or Recurrent Endometrial Cancer
In August 2024, the FDA expanded approval status for dostarlimab-gxly plus carboplatin/paclitaxel followed by single-agent dostarlimab to include all adult patients with primary advanced or recurrent endometrial cancer.
The second interim analysis of the phase 3 RUBY trial found the safety profile was consistent with the first interim analysis and no new deaths due to AEs were observed.
The phase 3 RUBY trial evaluated dostarlimab in combination with carboplatin/paclitaxel in patients with primary advanced or recurrent endometrial cancer.