FDA Grants Breakthrough Status to AbbVie’s Temab-A for Lung and Colon Cancer

The designations cover two distinct patient populations. For colorectal cancer, the FDA recognized the drug when used in combination with bevacizumab for patients with metastatic disease who have exhausted standard regimens, including anti-VEGF and anti-EGFR therapies. In the lung cancer cohort, Temab-A received clearance as a monotherapy for patients with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing non-squamous disease following platinum-based chemotherapy and immunotherapy.

These decisions are rooted in data from the M21-404 first-in-human study. By targeting the c-Met protein, which often drives tumor resistance, AbbVie aims to address high-mortality cancers that have proven difficult to treat with current standards. Eleni Lagkadinou, vice president of oncology early development at AbbVie, noted that the clinical evidence reinforces the potential of the c-Met pathway across multiple solid tumors. The company is currently evaluating the asset in a broad clinical program covering various advanced cancers, including head and neck squamous cell carcinoma and ovarian cancer, as it seeks to expedite the path toward regulatory approval for these high-need indications.