AbbVie secures two FDA Breakthrough Therapy Designations for Temab-A

• AbbVie received two FDA Breakthrough Therapy Designations for its investigational drug telisotuzumab adizutecan.
• The regulatory designations target refractory metastatic colorectal cancer and advanced c-Met protein-expressing lung cancer.
• The company expects its Phase 3 and Phase 2/3 clinical studies to further evaluate the asset as a monotherapy and in combination treatments.

AbbVie (NYSE:ABBV) received two FDA Breakthrough Therapy Designations for its investigational asset, telisotuzumab adizutecan (Temab-A).

The regulatory designations cover specific advanced indications across both colorectal cancer and non-small cell lung cancer.

The colorectal cancer designation covers combination treatment with bevacizumab for adults with refractory, metastatic disease previously treated with standard systemic therapies.

The lung cancer designation covers Temab-A monotherapy for adults with advanced c-Met protein-expressing non-squamous disease following platinum-based chemotherapy.

Both designations relied primarily on clinical evidence gathered from the first-in-human M21-404 study.

The company stated that its active development program includes Phase 3 and Phase 2/3 studies to evaluate safety and efficacy across various treatment settings.