GSK's (GSK) Jemperli has been accepted by the US Food and Drug Administration for priority review of its supplemental biologics license application for patients with previously untreated rectal cancer, the company said Monday.

The specific indication is for patients with locally advanced stage II and III rectal cancer with mismatch repair deficient/microsatellite instability-high, the company said.

The FDA has assigned an action date of February 2027 for the drug, the company said.

The application was based on data from a phase II trial, which met its primary objective by showing a "meaningful and sustained " clinical complete response rate for 12 months and a consistent safety and tolerability profile, the company said.

If approved, the drug could eliminate the need for chemotherapy, radiation, and surgery for some rectal cancer patients, the company said.