- FDA granted accelerated approval to Jemperli (dostarlimab-gxly) alone for adults with previously untreated stage II or III locally advanced rectal cancer that is dMMR or MSI-H, as determined by an FDA-authorized test.
- The approval rests on interim AZUR-1 data from 154 patients, where almost three-fourths had not needed surgery, radiotherapy or chemotherapy after a median follow-up of more than 2 years.
- The approval was granted to GSK. The sponsor must continue following patients to confirm lasting clinical benefit, and the FDA completed the review nearly 4 months ahead of schedule.
Quotes
“Completing this review nearly 4 months ahead of schedule means some patients who might otherwise be preparing for surgery, radiation or chemotherapy may now have a different conversation with their doctor.”
“Standard treatment for rectal cancer has major life-changing effects.”