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

$ABBVPress releaseOct 7, 2026, 8:30 AM ETRead the release

The FDA granted two Breakthrough Therapy Designations to AbbVie's c-Met-directed ADC telisotuzumab adizutecan (Temab-A; ABBV-400), one for refractory metastatic CRC with bevacizumab and one for c-Met-expressing EGFR wild-type NSCLC as monotherapy. The designations are AbbVie's first BTDs for Temab-A, bringing its ADC portfolio to four total, and were based primarily on the first-in-human M21-404 study.

Key figures

Drug Name
telisotuzumab adizutecan (Temab-A; ABBV-400)
Phase Of Trial
Phase 3 and Phase 2/3 studies ongoing
Btd count
2
Adc portfolio btds
4

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