AbbVie’s Temab-A receives FDA Breakthrough Therapy Designations for CRC and NSCLC

CAR-T Digest - August 2020

07 October 2026: AbbVie’s Temab-A receives FDA Breakthrough Therapy Designations for CRC and NSCLC

AbbVie announced that the U.S. FDA has granted two Breakthrough Therapy Designations to Telisotuzumab adizutecan, its investigational c-Met-directed ADC, for refractory metastatic colorectal cancer in combination with bevacizumab and previously treated c-Met protein-expressing, EGFR wild-type non-squamous NSCLC as monotherapy
Both designations were primarily based on results from the first-in-human Phase 1 study M21-404 (NCT05029882), which demonstrated clinical activity across tumor types, supporting further development in heavily pretreated CRC and c-Met-expressing NSCLC populations
The designations address unmet needs in refractory mCRC after fluoropyrimidine-, irinotecan- and oxaliplatin-based chemotherapy and in advanced NSCLC following platinum chemotherapy and anti-PD-(L)1 therapy, where disease progression leaves patients with limited treatment options
Temab-A is a c-Met-directed ADC developed using AbbVie’s adizutecan platform, comprising a humanized IgG1 monoclonal antibody linked to a topoisomerase I inhibitor payload through a cleavable valine-alanine linker, designed to enable targeted cytotoxic delivery while limiting systemic payload release
Strategically, these are Temab-A’s first FDA Breakthrough Therapy Designations and bring AbbVie’s ADC portfolio to four assets with BTDs, strengthening its next-generation, biomarker-driven ADC strategy across multiple solid tumors