GSK’s Jemperli wins FDA priority review, potentially replacing rectal cancer surgery

The U.S. Food and Drug Administration (FDA) accepted GlaxoSmithKline’s application for Jemperli (dostarlimab) under Priority Review. This application seeks approval for treating dMMR/MSI-H primary advanced or recurrent rectal cancer.

Clinical trials showed a significant portion of participants had no detectable cancer for at least one year. Jemperli could become the first immunotherapy for this specific condition.

The drug may allow patients to avoid chemotherapy, radiation, and surgery. The FDA set a target decision date for February 2027.