FDA grants accelerated approval to an immunotherapy that may let some rectal cancer patients avoid chemotherapy, radiation and surgery

Oct. 19, 2026 — The Food and Drug Administration granted accelerated approval for Jemperli (dostarlimab-gxly) alone in adults with previously untreated stage II or III locally advanced rectal cancer whose tumors are mismatch repair deficient or microsatellite instability-high, the agency said. In a 154-patient study, almost three-fourths of patients had not needed surgery, radiotherapy or chemotherapy after a median follow-up of more than two years. Published estimates the agency cited put such tumors at about 3% of locally advanced rectal cancers. The drug can cause severe or fatal immune reactions, and the maker, GlaxoSmithKline, must confirm lasting benefit.

The wall: How long responses last has not been established; the approval rests on interim results.

Tier: Confirmed (based on the FDA's announcement)

Sources

• U.S. Food and Drug Administration, FDA Approves Immunotherapy That May Allow Certain Patients with Rectal Cancer to Avoid Chemotherapy, Radiation and Surgery (Oct. 19, 2026)

health, cancer

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