FDA Approves Atezolizumab With Chemotherapy for Stage III Mismatch Repair Deficient Colon Cancer
The FDA on Oct. 8 approved atezolizumab (Tecentriq) with fluoropyrimidine and oxaliplatin chemotherapy as adjuvant treatment for Stage III mismatch repair deficient colon cancer, based on the ATOMIC trial.
The Food and Drug Administration on Oct. 8 approved atezolizumab (Tecentriq, Genentech) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of Stage III mismatch repair deficient (dMMR) colon cancer, the agency said. The approval covers adult and pediatric patients two years of age and older.
The FDA also approved the related formulation atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech) in the same chemotherapy combination for patients 12 years and older who weigh at least 40 kilograms, according to the agency.
Trial showed improved disease-free survival
The decision was based on the ATOMIC trial (ML39057, NCT02912559), a randomized, open-label study of 711 adults and one pediatric patient whose Stage III dMMR colon tumors had been fully removed, the FDA said. Patients received either the atezolizumab combination followed by atezolizumab alone, or chemotherapy alone.
The combination improved disease-free survival, with a hazard ratio of 0.50 (95% CI: 0.35, 0.73; p-value 0.0001), according to the FDA. Median disease-free survival had not been reached in either group at the time of the analysis. The agency said the prescribing information carries warnings for immune-mediated adverse reactions, infusion-related reactions and embryo-fetal toxicity.
Reporting based on coverage by the U.S. Food and Drug Administration.
