AbbVie says FDA grants breakthrough therapy status for ABBV-400 in metastatic colorectal cancer
ABBV•AbbVie said the FDA granted two Breakthrough Therapy Designations for telisotuzumab adizutecan, also known as ABBV-400: one for refractory metastatic colorectal cancer with bevacizumab and one for advanced c-Met-expressing non-squamous NSCLC as monotherapy.
1. Two FDA designations
AbbVie said the FDA granted the designations based on outcomes from the first-in-human M21-404 study. Telisotuzumab adizutecan is an investigational c-Met-targeted antibody-drug conjugate.
