AbbVie Wins Two FDA Breakthrough Designations for Temab-A

NORTH CHICAGO, Ill., October 7, 2026

Temab-A Receives Two FDA Breakthrough Designations

The FDA granted one designation for Temab-A in combination with bevacizumab for adults with refractory metastatic colorectal cancer who have previously received fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and, when indicated, an anti-EGFR monoclonal antibody. The second designation covers 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 platinum-based chemotherapy and anti-PD-(L)1 antibody therapy. The designations were primarily supported by findings from M21-404, a first-in-human clinical study evaluating Temab-A. AbbVie said the regulatory milestones add to the clinical evidence supporting c-Met as a therapeutic target across multiple solid tumors. The FDA’s Breakthrough Therapy program is designed to accelerate the development and review of investigational medicines when preliminary clinical evidence indicates the potential for substantial improvement over available therapies on clinically significant endpoints.

AbbVie Advances Next-Generation ADC Technology

Temab-A is an investigational c-Met-directed ADC that combines a humanized bivalent IgG1 monoclonal antibody targeting the c-Met protein with a topoisomerase 1 inhibitor (Top1i) payload. The therapy uses a cleavable valine-alanine linker and stable bromoacetamide attachment as part of AbbVie’s adizutecan platform, with the goal of delivering the cytotoxic payload more selectively to tumor cells while limiting systemic payload release. The c-Met protein, also known as MET, can be expressed at increased levels in multiple solid tumors and may contribute to tumor progression and treatment resistance. By targeting c-Met, Temab-A is being investigated as a potential biomarker-driven approach for cancers in which this protein plays an important role. AbbVie is evaluating the candidate both as a monotherapy and in combination with other treatments across a broad range of advanced solid tumors. Beyond CRC and NSCLC, Temab-A is being studied in additional cancer indications, including head and neck squamous cell carcinoma (HNSCC), gastroesophageal adenocarcinoma (GEA), pancreatic ductal adenocarcinoma (PDAC), and ovarian cancer. Its clinical development program includes multiple Phase 3 and Phase 2/3 studies designed to evaluate the investigational ADC across different tumor types and treatment settings.

AbbVie Expands Its Oncology ADC Pipeline

The two Breakthrough Therapy Designations strengthen AbbVie’s broader strategy of developing targeted cancer therapies and next-generation ADCs. With the latest regulatory decisions, Temab-A contributes two additional BTDs to AbbVie’s ADC portfolio, which now includes four Breakthrough Therapy Designations. The company is advancing a wider oncology pipeline encompassing ADCs, immuno-oncology therapies, multispecific antibodies, small-molecule therapeutics and novel CAR-T platforms. AbbVie said the latest designations reinforce its focus on developing biomarker-driven therapies for patients with difficult-to-treat cancers. Colorectal cancer and lung cancer remain significant areas of unmet medical need, particularly for patients whose disease progresses despite multiple lines of standard treatment. Temab-A remains an investigational medicine and has not been approved by the FDA or any other global regulatory authority. The Breakthrough Therapy Designations are intended to facilitate development and regulatory interaction but do not guarantee approval or establish the therapy’s safety or efficacy. AbbVie will continue evaluating Temab-A across its clinical development program as it works toward determining the candidate’s potential role in the treatment of advanced solid tumors.

Source: AbbVie press release