BRIEF—EMA validates Jemperli marketing application variation

UK pharma major GSK today 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 gynecological 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 authorization 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, 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.

GSK expects US regulatory filing review based on the RUBY Phase III trial results to occur in the first half of 2023.