On October 7, 2026 AbbVie (NYSE: ABBV) reported 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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Temab-A has received two BTDs: one in combination with bevacizumab for adults with refractory, metastatic CRC who have been previously treated with fluoropyrimidine, irinotecan, oxaliplatin, anti-VEGF monoclonal antibody (mAb), and if indicated, anti-EGFR mAb therapy. The second designation is for Temab-A as a monotherapy for adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous NSCLC who have previously received treatment with platinum-based chemotherapy and an anti-PD-(L)1 antibody therapy. These designations were primarily based on results from the first-in-human study M21-404 (NCT05029882).

"These Breakthrough Therapy Designations reflect the growing clinical evidence supporting c-Met as a meaningful therapeutic target across multiple solid tumors," said Eleni Lagkadinou, M.D., Ph.D., 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. 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."

Colorectal and lung cancer together affect more than four million people worldwide each year and remain among the leading causes of cancer-related mortality.1,2 Despite advances in treatment, many patients with CRC and advanced NSCLC continue to experience disease progression, underscoring the need for new therapeutic approaches. The FDA’s BTD program is intended to expedite the development and review of investigational medicines with clinical evidence that may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

Temab-A is an investigational asset and has not been approved for use by global regulatory authorities.

About Telisotuzumab Adizutecan (Temab-A)

Telisotuzumab adizutecan (Temab-A) is a next-generation, c-Met protein-targeting antibody-drug conjugate (ADC) with a topoisomerase 1 inhibitor (Top1i) payload being investigated in advanced solid tumors including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). The c-Met protein (also known as MET protein), with increased expression in many solid tumors, may contribute to disease progression and treatment resistance, reinforcing its potential as a promising therapeutic target.

Developed using AbbVie’s adizutecan platform, Temab-A combines a validated, humanized bivalent IgG1 monoclonal antibody that binds with high affinity to the c-Met protein with the Top1i payload through a cleavable valine-alanine linker and stable bromoacetamide attachment. This design is intended to support targeted delivery while minimizing systemic payload release.

In addition to CRC and NSCLC, Temab-A is being evaluated across other multiple advanced solid tumors, including head and neck squamous cell carcinoma (HNSCC), gastroesophageal adenocarcinoma (GEA), pancreatic ductal adenocarcinoma (PDAC), and ovarian cancer (OC). The clinical development program includes multiple Phase 3 and Phase 2/3 studies evaluating Temab-A as both a monotherapy and in combination with other therapies across a range of treatment settings. Additional information about ongoing Temab-A clinical trials can be found on clinicaltrials.gov.

(Press release, AbbVie, OCT 7, 2026, View Source [SID1234673262])