The U.S. Food and Drug Administration (FDA) granted accelerated approval to GSK’s Jemperli (dostarlimab) for adults with stage II or III locally advanced rectal cancer whose tumors are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). It is the first and only immunotherapy approved for this patient group.
The decision was based on the AZUR-1 trial. A significant portion of participants had no detectable signs of cancer a year or more after treatment.
The approach could allow eligible patients to avoid standard treatments, including chemotherapy, radiation and life-altering surgery. Continued approval may depend on the results of confirmatory trials.