GSK’s Jemperli Wins FDA Nod for Endometrial Cancer
The FDA has granted accelerated approval to GlaxoSmithKline (GSK)’s monoclonal antibody Jemperli (dostarlimab) for treating women with recurrent or advanced endometrial cancer.
The approved indication is for patients whose disease has progressed during or following platinum-based chemotherapy and whose cancer contains a particular biomarker — deficient DNA mismatch repair (dMMR). The immunotherapy blocks PD-1 and PD-L1 proteins in the body’s immune system and in the cancer cells.
The approval was supported by a single arm in a multicohort study that enrolled 71 patients, with 42 percent of participants demonstrating a complete or partial response and 93 percent of the participants having a treatment response lasting six months or longer.
Jemperli received priority review and was granted a Breakthrough Therapy designation in 2019. The accelerated approval was granted as part of the agency’s Real-Time Oncology Review pilot program.