AnaptysBio says FDA approves Jemperli for locally advanced rectal cancer
ANAB•AnaptysBio announced FDA approval of GSK’s Jemperli as the first immunotherapy for adults with stage II-III MSI-H/dMMR locally advanced rectal cancer. In the AZUR-1 trial, no recurrences were reported among responders during median follow-up exceeding two years.
1. Approval and trial results
AnaptysBio announced FDA approval of GSK’s Jemperli for adults with stage II-III MSI-H/dMMR locally advanced rectal cancer. The AZUR-1 trial showed sustained complete responses, with a significant proportion of participants remaining cancer-free a year or more after treatment; no recurrences were reported among responders during median follow-up exceeding two years. Jemperli monotherapy could help eligible patients avoid chemotherapy, radiation and surgery, and its safety profile was generally consistent with previous findings. GSK will present full interim results at the ESMO Congress in Madrid on October 25, 2026.
