The FDA has granted accelerated approval to an immunotherapy that may spare some patients with locally advanced rectal cancer from undergoing chemotherapy, radiation and surgery.
The approval covers London-based GSK’s dostarlimab-gxly — sold under the brand name Jemperli — as a standalone treatment for adults with previously untreated stage 2 or 3 locally advanced rectal cancer, according to an Oct. 19 news release from the agency.
Eligible patients’ tumors must be identified by an FDA-authorized test as mismatch repair-deficient or microsatellite instability-high, the release said.
The FDA based its decision on interim results from a phase 2 trial involving 154 patients. After a median follow-up of more than two years, nearly three-quarters of patients had not needed surgery, radiation or chemotherapy. An earlier study of 50 patients at New York City-based Memorial Sloan Kettering Cancer Center found that 93% remained cancer-free for at least 12 months after treatment with Jemperli.
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