NCT05029882
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AbbVie said on October 7, 2026 that the FDA granted two breakthrough therapy designations to telisotuzumab adizutecan (Temab-A; ABBV-400), its c-Met antibody-drug conjugate. One covers the drug with bevacizumab in adults with refractory metastatic colorectal cancer previously treated with fluoropyrimidines, irinotecan, oxaliplatin, anti-VEGF and, where applicable, anti-EGFR monoclonal antibodies; the other covers it alone in locally advanced or metastatic EGFR wild-type, c-Met protein-expressing non-squamous NSCLC after platinum chemotherapy and anti-PD-(L)1 treatment. Both designations rest on results from the first-in-human study M21-404 (NCT05029882).
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- mp.weixin.qq.comFDA Grants AbbVie c-Met ADC Telisotuzumab Adizutecan Breakthrough Designations in CRC and NSCLC
AbbVie said on October 7, 2026 that the FDA granted two breakthrough therapy designations to telisotuzumab adizutecan (Temab-A; ABBV-400), its c-Met antibody-drug conjugate. One covers the drug with bevacizumab in adults with refractory metastatic colorectal cancer previously treated with fluoropyrimidines, irinotecan, oxaliplatin, anti-VEGF and, where applicable, anti-EGFR monoclonal antibodies; the other covers it alone in locally advanced or metastatic EGFR wild-type, c-Met protein-expressing non-squamous NSCLC after platinum chemotherapy and anti-PD-(L)1 treatment. Both designations rest on results from the first-in-human study M21-404 (NCT05029882).
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