GSK’s Jemperli Gets Regular Approval for Endometrial Cancer

The FDA has granted regular approval — one month ahead of the FDA goal date — to GSK’s Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair deficient recurrent or advanced endometrial cancer that progressed on or after a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.

Jemperli is a PD-1 blocking antibody intravenous drug which awakens a repressed immune system to stimulate an anti-tumor immune response rather than target a particular cancer molecule. The drug was granted accelerated approval in April 2021.

The agency decision to move to regular approval was based on long-term results from an ongoing phase 1 clinical trial which showed an overall response rate of 45.4 percent.