GSK announced that the U.S. Food and Drug Administration granted accelerated approval to Jemperli (dostarlimab-gxly) for a specific type of locally advanced rectal cancer. It is the first and only immunotherapy approved for adults with previously untreated stage II or III rectal cancer whose tumors have MSI-H or dMMR biomarkers. These biomarkers are present in about 5% to 10% of rectal cancer cases.
The treatment may offer an alternative to standard care, which can include chemotherapy, radiation and surgery. Approval was based on the AZUR-1 trial, in which Jemperli monotherapy produced a high rate of sustained clinical complete response. A significant portion of patients had no signs of cancer after treatment and avoided traditional interventions.