The FDA has granted two breakthrough therapy designations to AbbVie’s investigational cancer drug telisotuzumab adizutecan, covering previously treated colorectal cancer and non-small cell lung cancer. The drug, also known as Temab-A or ABBV-400, remains unapproved by global regulatory authorities.
One designation covers Temab-A combined with bevacizumab for adults with refractory metastatic colorectal cancer previously treated with fluoropyrimidine, irinotecan, oxaliplatin and an anti-VEGF monoclonal antibody, plus anti-EGFR therapy when indicated.
The second covers Temab-A alone for adults with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors express c-Met protein and have wild-type EGFR. Eligible patients must have previously received platinum-based chemotherapy and an anti-PD-(L)1 antibody.
AbbVie said both designations were based primarily on results from the first-in-human M21-404 study. They are the first breakthrough therapy designations awarded to Temab-A.
The FDA program is intended to expedite development and review of investigational medicines when clinical evidence indicates they may substantially improve on existing therapies on one or more clinically significant endpoints.
Temab-A is an antibody-drug conjugate targeting c-Met, a protein whose increased expression in solid tumors may contribute to disease progression and treatment resistance. It combines a c-Met-binding antibody with a topoisomerase 1 inhibitor payload, using a cleavable linker designed to support targeted delivery while limiting systemic payload release.
The development program includes Phase 3 and Phase 2/3 studies of Temab-A alone and in combinations. AbbVie is also evaluating the drug in head and neck, gastroesophageal, pancreatic and ovarian cancers across multiple advanced solid tumor settings.
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