FDA grants AbbVie's Temab-A two breakthrough therapy designations

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Go back to FDA grants AbbVie's Temab-A two breakthrough therapy designations

AbbVie's Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the U.S. FDA for CRC and NSCLC

October 7, 2026 8:30 AM EDT

Temab-A is an investigational, next-generation, c-Met-directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) being studied in advanced solid tumors including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) These designations represent the first Breakthrough Therapy Designations (BTDs) for Temab-A and further underscore the strength of AbbVie's ADC portfolio, which now includes four BTDs

NORTH CHICAGO, Ill., Oct. 7, 2026 /PRNewswire/... More