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.