GSK’s Jemperli Gets OK for Endometrial Cancer

FDA has granted full approval to GSK’s Jemperli (dostarlimab-gxly) for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation. Previously, the drug was marketed under an accelerated approval in this patient population.

The full approval was based on data from the GARNET (NCT02715284) trial that demonstrated a confirmed objective response rate of 45%, a 15.6% complete response rate and a 29.8% partial response rate, an FDA release says. The most common adverse reactions (in greater than 20% of patients) were fatigue/asthenia, anemia, rash, nausea, diarrhea, constipation, and vomiting. Immune-mediated adverse reactions can occur including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin adverse reactions, it says.