FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer
On October 19, 2026 the FDA granted accelerated approval to dostarlimab (Jemperli, GSK) for adults with Stage II/III locally advanced rectal cancer that is microsatellite instability high or mismatch repair deficient. The approval was based on AZUR-1, a single-arm trial of 154 patients that reported a 47% sustained clinical complete response at 12 months per independent central review.
Primary source
FDA approval notification, October 19, 2026
FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer
Read the source: FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer fda.gov
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