AbbVie’s Experimental Cancer Drug Temab-A Earns Two FDA Breakthrough Designations for Advanced Colorectal and Lung Cancers

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VANDERLEI ALMEIDA | AFP via Getty Images Share on Twitter Share on Facebook Share on Pocket The FDA has granted two Breakthrough Therapy designations to telisotuzumab adizutecan, or Temab-A, an experimental AbbVie drug for advanced colorectal and lung cancers, the company announced in a press release on Oct. 7. The status can speed the drug’s development and review, but it is not an approval.

One designation covers Temab-A combined with bevacizumab for adults with metastatic colorectal cancer that keeps progressing after standard chemotherapy and targeted drugs. The other covers Temab-A alone for adults with advanced non-squamous non-small cell lung cancer that is EGFR wild-type and expresses the c-Met protein, after platinum chemotherapy and immunotherapy.

For families of patients who have run through standard options, the news offers a possible future treatment, not an immediate one. AbbVie’s announcement did not include efficacy figures, and the drug is still being tested.

Temab-A is an antibody-drug conjugate. It pairs an antibody that seeks out c-Met, a protein found at higher levels on many tumors, with a chemotherapy-like payload that blocks an enzyme cancer cells need to copy DNA. The design aims to deliver the payload directly to tumor cells while limiting exposure elsewhere.

“These Breakthrough Therapy Designations reflect the growing clinical evidence supporting c-Met as a meaningful therapeutic target across multiple solid tumors,” said Dr. Eleni Lagkadinou, vice president of oncology early development at AbbVie. She added that Temab-A “has demonstrated potential across multiple tumor types, both as a monotherapy and in combinations.” The company said both designations were based mainly on its first-in-human phase 1 study, known as M21-404.

These are the first breakthrough designations for Temab-A, and AbbVie said its antibody-drug conjugate portfolio now holds four. Beyond colorectal and lung cancer, the company is testing Temab-A in head and neck, gastroesophageal, pancreatic, and ovarian cancers through several phase 3 and phase 2/3 studies.

Earlier data offer some context. In results presented at the 2025 European Society for Medical Oncology Congress and summarized by OncLive, 30 patients given the higher Temab-A dose with bevacizumab went a median 6.8 months before their cancer worsened. That compared with 4.2 months for 20 patients on a standard regimen of trifluridine/tipiracil plus bevacizumab.

Median overall survival had not yet been reached in the higher-dose group, compared with 9.6 months in the standard-care group. A third group of 26 patients on a lower Temab-A dose went a median 5.6 months before progression and lived a median 9.8 months. Those numbers came from a data cutoff in May 2025, so longer follow-up could change the picture.

Those groups were small, and patients were not selected by c-Met levels. Side effects were common. Among 63 patients who received Temab-A, 37% had severe (grade 3 or higher) anemia, and nausea, fatigue, and vomiting each affected 40% or more. Lung inflammation occurred in 5%, including one severe case.

MedicalDaily Evidence Check: The evidence comes from an early-phase, company-sponsored trial reported at a medical conference and in a company press release. No independent experts were quoted in AbbVie’s announcement, and comparable published data for the lung cancer designation were not provided.

The FDA describes Breakthrough Therapy designation as a process to speed the development and review of drugs for serious conditions when preliminary evidence suggests substantial improvement over available therapy. It brings more intensive FDA guidance, but the drug still has to prove itself in larger trials. Companies request the designation, and the FDA responds within 60 days.

That test is underway. The phase 3 AndroMETa-CRC trial compares Temab-A plus bevacizumab with trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer, with response rate and overall survival as primary goals. A key secondary goal is whether survival differs by c-Met levels, which could help clarify which patients benefit most. AbbVie has not announced a filing timeline.

The need is real. The American Cancer Society estimates about 55,230 Americans will die of colorectal cancer in 2026, and the group’s 2026 report found that 45% of new cases occur in adults under 65. AbbVie noted that colorectal and lung cancer together affect more than four million people worldwide each year.

The people most directly affected are those who have already exhausted several lines of treatment. For colorectal cancer, that means patients whose disease progressed after fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF drug, and, when appropriate, an anti-EGFR drug. For lung cancer, the designation applies only to tumors without EGFR mutations that test positive for c-Met protein, a smaller group of patients.

Patients with advanced colorectal or lung cancer can ask their oncologist whether a Temab-A trial or another study fits their situation. Lung cancer patients may also ask whether their tumor has been tested for c-Met protein expression and EGFR mutations, since both results determine whether the lung cancer designation would apply to them.

AbbVie lists an expanded access program for Temab-A, generally for people who do not qualify for trials and lack other suitable options. A doctor must decide whether the potential benefit outweighs the risk, and availability depends on location.

Anyone considering a trial should ask which costs the sponsor covers and which fall to insurance, along with how often travel to a study site would be needed. No one should stop current treatment without speaking with their care team.

What comes next depends on the phase 3 results. A breakthrough designation can shorten the path to a decision, but AbbVie still has to file for approval, and the FDA still has to judge whether the benefit outweighs side effects like anemia and lung inflammation. Until then, Temab-A is available only through research settings.

Temab-A, or telisotuzumab adizutecan, is an experimental antibody-drug conjugate from AbbVie that targets the c-Met protein on tumor cells and delivers a cell-killing payload.

No. Breakthrough Therapy designation speeds development and review, but the drug has not been approved by the FDA or any other regulator.

Which patients do the designations cover?

Adults with previously treated metastatic colorectal cancer, when Temab-A is combined with bevacizumab, and adults with previously treated, c-Met protein-expressing, EGFR wild-type non-squamous lung cancer.

AbbVie released no new efficacy data. Earlier phase 1 results showed a median 6.8 months without colorectal cancer progression in a small group, compared with 4.2 months on standard treatment.

Patients can ask their oncologist about clinical trials, including the phase 3 AndroMETa-CRC study, or about AbbVie’s expanded access program.