The FDA on Oct. 8 approved Genentech’s Tecentriq (atezolizumab) with chemotherapy as an adjuvant treatment for adults and children ages 2 and older with stage 3 mismatch repair-deficient colon cancer.
The approval covers Tecentriq combined with a fluoropyrimidine and oxaliplatin. The FDA also approved Tecentriq Hybreza, a subcutaneous form of atezolizumab and hyaluronidase-tqjs, with the same chemotherapy for patients ages 12 and older who weigh at least 40 kilograms.
The decision is based on the ATOMIC trial, a randomized, open-label study of 711 adults and one pediatric patient. All participants had complete resection of the primary tumor and no residual lymph node involvement or metastatic disease. One group received atezolizumab plus standard FOLFOX chemotherapy for 12 cycles and then six months of atezolizumab alone. The other group received chemotherapy alone.
Disease-free survival, the trial’s main efficacy measure, had a hazard ratio of 0.50 for the atezolizumab group compared with chemotherapy alone. Neither group reached median disease-free survival.
Adults receive intravenous Tecentriq every two, three or four weeks with chemotherapy for six months. After that, they continue on atezolizumab alone for six months or until the disease returns or side effects become unacceptable. Tecentriq Hybreza is given as one 15-milliliter injection every three weeks.
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