GSK plc (NYSE: GSK), a leading UK pharmaceutical company, has announced that the European Commission (EC) has granted a new indication approval for its programmed death-1 (PD-1) inhibitor, Jemperli (dostarlimab). The approval allows for the use of Jemperli in combination with carboplatin-paclitaxel, a chemotherapy regimen, for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. This decision follows an earlier conditional approval from the EC for Jemperli as a monotherapy for the same indication, which has now been upgraded to a full approval.
The latest approval significantly broadens the patient population that can benefit from Jemperli’s treatment. The approval was supported by data from the dMMR/MSI-H cohort of Part 1 in the RUBY/ENGOT-EN6/GOG3031/NSGO Phase III study. The study demonstrated that the Jemperli combination therapy led to a notable improvement in progression-free survival (PFS), with a 72% reduction in the risk of disease progression or death compared to chemotherapy alone (HR: 0.28 [95% CI: 0.16-0.50]).- Flcube.com
