FDA has granted accelerated approval of an immunotherapy for adults with previously untreated stage II or III locally advanced rectal cancer whose tumors are dMMR or MSI-H.
In a phase 2 study, almost three-fourths of patients did not need surgery, radiotherapy, or chemotherapy after a median follow-up of more than 2 years. For eligible patients, treatment may help avoid chemotherapy, radiation and surgery and their lasting effects.
This is the 11th approval under the Commissioner’s National Priority Voucher pilot program.
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Illustration showing two cells representing immunotherapy interacting, with a small inset image of a highlighted colon. Text states: "FDA grants accelerated approval of immunotherapy for certain patients with rectal cancer.