FDA Prioritizes Review of Jemperli for Locally Advanced Rectal Cancer

The FDA has accepted Jemperli (dostarlimab) for priority review as a treatment for previously untreated stage II and III dMMR/MSI-H locally advanced rectal cancer. This decision is based on the AZUR-1 trial, which showed many patients had no detectable cancer after treatment, potentially reducing the need for traditional therapies like chemotherapy, radiation, and surgery. A PDUFA action date is set for February 2027.