Rectal cancer: US approves immunotherapy that may spare surgery and chemo
The FDA granted accelerated approval to GSK's Jemperli (dostarlimab) for a small group of patients with locally advanced rectal cancer. Some may avoid surgery, radiation and chemotherapy.
Photo: The U.S. Food and Drug Administration / Wikimedia Commons, Public domain (cropped and resized)
The US Food and Drug Administration on Oct. 19 granted accelerated approval to the immunotherapy Jemperli (dostarlimab) from drugmaker GSK. It is for adults with untreated stage II or III locally advanced rectal cancer whose tumour is mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H). Published estimates cited by the FDA put that at about 3% of such cases.
The approval is based on interim results from the AZUR-1 trial of 154 patients, who received up to nine doses every three weeks. After a median follow-up of more than two years, almost three-quarters had not needed surgery, radiotherapy or chemotherapy, the FDA said. In an earlier Memorial Sloan Kettering study of 50 patients, 93% remained cancer-free for at least 12 months.
Standard treatment can affect bowel, urinary and sexual function as well as fertility, the agency said. The FDA lists fatigue, rash, diarrhoea and itching as the most common side effects; the immune system can also attack healthy organs, which can be severe or even fatal. Because the approval is accelerated, the maker must confirm lasting benefit in further studies. Patients should discuss treatment options with their oncologist.
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