AbbVie's Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the U.S. FDA for CRC and NSCLC
Key Highlights
- ➤Temab-A receives two FDA Breakthrough Therapy Designations for CRC and NSCLC
- ➤CRC designation covers Temab-A combined with bevacizumab in previously treated metastatic disease
- ➤NSCLC designation covers Temab-A monotherapy in previously treated EGFR wild-type disease
- ➤AbbVie’s ADC portfolio now includes four Breakthrough Therapy Designations
- ➤Temab-A remains investigational and has not received global regulatory approval
Expert Statements
Eleni Lagkadinou, Vice president, oncology early development, AbbVie
“These Breakthrough Therapy Designations reflect the growing clinical evidence supporting c-Met as a meaningful therapeutic target across multiple solid tumors.”
Eleni Lagkadinou, Vice president, oncology early development, AbbVie
“As one of the most advanced assets in our next-generation ADC portfolio, Temab-A has demonstrated potential across multiple tumor types, both as a monotherapy and in combinations.”
Eleni Lagkadinou, Vice president, oncology early development, AbbVie
“We believe these designations further support our strategy of advancing biomarker-driven therapies and underscore our commitment to developing transformative medicines for patients with difficult-to-treat cancers.”
AbbVie's Telisotuzumab Adizutecan (Temab-A) Receives Two Breakthrough Therapy Designations From the U.S. FDA for CRC and NSCLC PR Newswire
* 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/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted two Breakthrough Therapy Designations (BTDs) for telisotuzumab adizutecan (Temab-A; ABBV-400) in colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).
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