FDA grants AbbVie's Temab-A two breakthrough therapy designations for colorectal and lung cancer

Overview

Updated 1 hour ago

The FDA granted AbbVie's experimental cancer drug Temab-A two breakthrough therapy designations on October 7. One covers colorectal cancer, the other non-small cell lung cancer. The designations speed up development and review for drugs that show early evidence of substantial improvement over existing therapies.

Temab-A is an antibody-drug conjugate that delivers a chemotherapy payload to cells carrying the c-Met protein, which is overexpressed in many solid tumors. The designations rest on phase 1 data showing the drug shrank tumors in patients who had already failed multiple lines of treatment. AbbVie is now running a phase 3 trial in colorectal cancer.

Why it matters

If Temab-A clears phase 3, patients with refractory colorectal and lung cancer gain a new option where standard treatments fail.

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Key Indicators

Breakthrough therapy designations granted

One for refractory metastatic colorectal cancer, one for previously treated c-Met-expressing non-small cell lung cancer.

47.9%

Objective response rate in NSCLC

Across 48 patients with EGFR wild-type non-squamous NSCLC in phase 1 study M21-404.

6.8 months

Median progression-free survival in CRC combination cohort

Temab-A at 2.4 mg/kg plus bevacizumab versus 4.2 months for standard-of-care TAS-102 plus bevacizumab.

520

Patients enrolled in phase 1 study

Study M21-404 is active but not recruiting, with primary completion estimated for November 2027.

Voices

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People Involved

Eleni Lagkadinou

Vice president, oncology early development, AbbVie

Leading early development of Temab-A

Organizations Involved

AbbVie (Allergan)

Pharmaceutical company

Developer of Temab-A

Global biopharmaceutical company developing Temab-A, a c-Met-directed antibody-drug conjugate.

U.S. Food and Drug Administration

Federal regulatory agency

Granted breakthrough therapy designations

The U.S. Food and Drug Administration regulates drug approvals and grants breakthrough therapy designations to expedite development of promising therapies for serious conditions.

Timeline

October 2021 October 2026

4 events Latest: Today

Tap a bar to jump to that date

October 2026
FDA grants two breakthrough therapy designations
Today Regulatory

FDA grants Temab-A breakthrough therapy designations in colorectal cancer and non-small cell lung cancer, based on phase 1 data.
Today
September 2025
Phase 1 data presented at ESMO 2025
Conference

AbbVie presents data showing Temab-A plus bevacizumab improves progression-free survival in refractory colorectal cancer.
September 2025
May 2025
Data cutoff for colorectal cancer cohort
Clinical Data

Data cutoff for the Temab-A plus bevacizumab combination cohort in refractory metastatic colorectal cancer.
May 29th, 2025
October 2021
Phase 1 study M21-404 begins
Clinical Trial

AbbVie launches a first-in-human study of Temab-A, alone and with bevacizumab, in adults with advanced solid tumors.
October 13th, 2021

Scenarios

Temab-A wins FDA approval in colorectal cancer

Possible Resolves by End of 2029

Discussed by: AbbVie and oncology analysts tracking the phase 3 AndroMETa-CRC trial

The phase 3 AndroMETa-CRC trial compares Temab-A plus bevacizumab against standard-of-care TAS-102 plus bevacizumab in refractory metastatic colorectal cancer. Phase 1 data showed a median progression-free survival of 6.8 months versus 4.2 months for standard care. If the larger trial confirms an overall survival benefit, AbbVie would file for approval, and the breakthrough designation would speed review.

Temab-A wins FDA approval in non-small cell lung cancer

Possible Resolves by End of 2029

Discussed by: AbbVie; the NSCLC monotherapy designation signals FDA interest in the c-Met target

The NSCLC designation covers Temab-A as monotherapy for EGFR wild-type, c-Met-expressing non-squamous disease after platinum-based chemotherapy and anti-PD-(L)1 therapy. Phase 1 data showed a 47.9% response rate, with higher responses in patients with higher c-Met expression. AbbVie would need a confirmatory phase 3 trial before filing.

Phase 3 trial disappoints, Temab-A development stalls

Unlikely Resolves by End of 2029

Discussed by: Oncology analysts noting the phase 1 data came from a small, biomarker-unselected population

The colorectal cancer phase 1 data came from 30 patients. If the larger phase 3 trial fails to confirm the benefit, or if safety issues emerge, AbbVie would need to narrow the indication or abandon the program. The phase 1 study showed dose-dependent hematologic toxicity and a 5% rate of interstitial lung disease.

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

2017-2020

Enhertu (trastuzumab deruxtecan) — ADC breakthrough designations (2017-2020)

Daiichi Sankyo and AstraZeneca developed Enhertu, an antibody-drug conjugate targeting HER2. It received multiple breakthrough therapy designations and showed responses in breast, gastric, and lung cancers where earlier HER2-targeted therapies had limited effect.

Then

The FDA approved Enhertu in 2019 for HER2-positive breast cancer, and it expanded to additional indications over the following years.

Now

Enhertu became one of the best-selling cancer drugs, validating the ADC class and the strategy of targeting proteins that drive tumor growth.

Why this matters now

Like Enhertu, Temab-A is an ADC that has received multiple breakthrough designations across tumor types, suggesting c-Met could follow a similar path.

August 2011

Adcetris (brentuximab vedotin) — first ADC approval (2011)

The FDA approved Adcetris in 2011, the first antibody-drug conjugate for Hodgkin lymphoma. It delivered a chemotherapy payload directly to CD30-positive cancer cells, sparing healthy tissue.

Then

Adcetris established the ADC class and showed that targeted chemotherapy delivery could work in the clinic.

Now

The ADC class has grown into a multi-billion-dollar market with dozens of approved drugs across cancer types.

Why this matters now

Temab-A builds on the ADC mechanism Adcetris pioneered, applying it to the c-Met target in solid tumors.