The FDA granted accelerated approval on Oct. 19 to Jemperli, an immunotherapy that may let some people with locally advanced rectal cancer avoid surgery, radiation, and chemotherapy. The approval is based on interim trial results, and the drugmaker must keep following patients to confirm that the benefit lasts, the FDA said.
The drug, made by GSK and known generically as dostarlimab-gxly, is approved only for adults with previously untreated stage II or III rectal cancer whose tumors are mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). That status must be confirmed with an FDA-authorized test. The decision came ahead of a February 2027 target date, OncLive reported.
