AbbVie's Temab-A Gets Two FDA Breakthrough Therapy Tags in Cancer

What happened: AbbVie said the FDA granted two Breakthrough Therapy designations to its investigational ADC telisotuzumab adizutecan (Temab-A; ABBV-400), for colorectal cancer and non-small cell lung cancer. These are the first BTDs for Temab-A. Key numbers: Year to date, AbbVie shares rallied 21.6% versus an 11.7% industry increase. Both designations were based on the first-in-human M21-404 study. Why it matters: The designations support a pipeline AbbVie is expanding with ADCs, and the company expects pivotal data readouts for Temab-A in metastatic CRC. Market: +1.5% by next close ($276.47 on Oct 9), +25.7% YTD

AbbVie said the FDA granted two Breakthrough Therapy designations to its investigational ADC telisotuzumab adizutecan (Temab-A; ABBV-400), for colorectal cancer and non-small cell lung cancer. These are the first BTDs for Temab-A.

The designations support a pipeline AbbVie is expanding with ADCs, and the company expects pivotal data readouts for Temab-A in metastatic CRC. Market: +1.5% by next close ($276.47 on Oct 9), +25.7% YTD