AbbVie's Telisotuzumab Adizutecan Receives Two FDA Breakthrough Therapy Designations for Colorectal and Non-Small Cell Lung Cancers

The U.S. Food and Drug Administration (FDA) has granted two Breakthrough Therapy Designations (BTDs) to telisotuzumab adizutecan (Temab-A) for the treatment of colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). One BTD is for Temab-A in combination with bevacizumab for adults with refractory, metastatic CRC, and the second is for Temab-A as a monotherapy for adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous NSCLC. These designations are based on results from the M21-404 study and aim to accelerate the development and review of this investigational antibody-drug conjugate.