09/10/2026
The US Food and Drug Administration has granted two Breakthrough Therapy Designations at once to AbbVie's experimental antibody-dr*g conjugate Temab-A, also called telisotuzumab adizutecan, for metastatic colorectal cancer and non-small cell lung cancer. The decision, announced on October 7, 2026, is based on early results from the first-in-human M21-404 study.
Temab-A is a next-generation c-Met-directed antibody-dr*g conjugate designed to find tumor cells and deliver a targeted cancer treatment payload directly to them. With these two designations, AbbVie's ADC portfolio now holds four Breakthrough Therapy Designations in total, one of the strongest early signals for the c-Met target in solid tumors.
The breakthrough label does not mean approval yet, but it speeds up the FDA review and gives AbbVie closer guidance as larger trials move forward. Patients and families following colorectal and lung cancer research will want to watch for the next round of study data.
Source: CURE Today (Oct 7, 2026) https://www.CureToday.com/view/fda-grants-breakthrough-therapy-designations-to-abbvies-temab-a-in-colorectal-and-lung-cancers
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