Isophoric News · Thursday, October 22, 2026
FDA grants accelerated approval to GSK's Jemperli for a small group of patients with locally advanced rectal cancer
The Food and Drug Administration granted accelerated approval Oct. 19 for GSK's immunotherapy Jemperli (dostarlimab-gxly), used alone, in adults with previously untreated stage II or III locally advanced rectal cancer whose tumors are mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) as determined by an FDA-authorized test, the agency said; published estimates suggest about 3% of locally advanced rectal cancers have that feature. The approval rests on interim results from AZUR-1, a phase 2 study of 154 patients, in which after a median follow-up of more than two years almost three-fourths had not needed surgery, radiotherapy or chemotherapy, and the FDA says longer follow-up is needed to understand how long responses last and how often the cancer returns. Jemperli can cause the immune system to attack healthy organs and tissues, with reactions that can be severe or fatal, and the most common side effects were fatigue, rash, diarrhea and itching, the FDA said. Because the approval is accelerated, GSK must keep following patients to show the responses translate into lasting benefit, according to the FDA and MedCity News.
