rectal cancer
Stories
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FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer
The FDA granted accelerated approval to dostarlimab (Jemperli, GSK) on October 19, 2026 for Stage II/III locally advanced rectal cancer that is MSI-H or dMMR. The FDA said the AZUR-1 trial of 154 patients reported a 47% sustained clinical complete response at 12 months per independent central review.
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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.