AbbVie Says Telisotuzumab Adizutecan Receives Two US FDA Breakthrough Therapy Designations to Treat Colorectal Cancer, Lung Cancer
MT newswire2026/10/07 13:1609:16 AM EDT, 10/07/2026 (MT Newswires) -- AbbVie (ABBV) said Wednesday that the US Food and Drug Administration has granted two Breakthrough Therapy Designations for telisotuzumab adizutecan to treat colorectal cancer and to treat non-small cell lung cancer. The company said one of the designations covers a combination with bevacizumab for adults with refractory, metastatic colorectal cancer who have been treated with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF monoclonal antibody, and anti-epidermal growth factor receptor monoclonal antibody therapy. The second designation is as a monotherapy for adults with locally advanced or metastatic epidermal growth factor receptor wild-type, c-Met protein-expressing, non-squamous non-small cell lung cancer who have previously received treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy. The company said the designations were based mainly on results from the first-in-human study M21-404.
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