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Oct 9Fri
  1. fda.gov93

    FDA approves atezolizumab in combination with chemotherapy for Stage III mismatch repair deficient colon cancer

    The FDA approved atezolizumab (Tecentriq, Genentech) in combination with a fluoropyrimidine and oxaliplatin on October 8, 2026, for adjuvant treatment of Stage III mismatch repair deficient colon cancer in patients two years of age and older, with the subcutaneous Tecentriq Hybreza approved for those 12 years and older weighing 40 kg or greater. In the ATOMIC trial of 711 adults and one pediatric patient, the hazard ratio for disease-free survival was 0.50 versus mFOLFOX6 alone, and median DFS was not reached in either arm. Reviews are ongoing at partner agencies under Project Orbis.

    Why it matters: FDA approval of atezolizumab plus chemotherapy as adjuvant therapy for Stage III dMMR colon cancer, with a disease-free survival hazard ratio of 0.50.

Oct 1Thu
  1. biopharmadive.com50

    FDA starts review of Roche’s multiple sclerosis pill

    The FDA has accepted Roche's approval application for fenebrutinib, an experimental multiple sclerosis pill, under a priority review with a six-month timeline, covering both relapsed and primary progressive forms of the disease. The application rests on three late-stage studies that met their main objectives, but approval chances could be complicated by an imbalance in deaths, eight among fenebrutinib recipients versus one on Aubagio in two Phase 3 trials, and a case of liver enzyme elevations meeting Hy's law. Roche did not say when a decision might come.

    Why it matters: Fenebrutinib could become the first BTK inhibitor approved for two major forms of MS despite unresolved safety concerns.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org