Approval Expanded for Dostarlimab

Today, the FDA expanded the indication for dostarlimab (Jemperli; GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab, to treat adults with primary advanced or recurrent endometrial cancer. This treatment regimen for the drug, which binds to PD1 to block interactions with PD-L1 and PD-L2, was OK’d in July 2023 to treat primary advanced or recurrent endometrial cancer that is mismatch repair-deficient or microsatellite instability-high. The new approval was based on results of the phase III RUBY study, which found statistically significant improvements in progression-free survival and overall survival in the cohort that received dostarlimab compared with the group that received placebo with carboplatin and paclitaxel followed by placebo.