AbbVie receives two FDA breakthrough designations for Temab‑A
The designations cover a colorectal cancer combination and lung cancer monotherapy, both based mainly on a first-in-human study.
Adrian Kessler
Closer FDA guidance is available for two Temab-A cancer programs after AbbVie Inc. NYSEABBV said on Oct. 7 that the agency granted Breakthrough Therapy designations in colorectal and non-small cell lung cancer.
The company's Oct. 7 statement names Temab-A plus bevacizumab for adults with refractory metastatic colorectal cancer previously treated with fluoropyrimidine, irinotecan, oxaliplatin and anti-VEGF therapy. Prior anti-EGFR therapy is also required when indicated. The lung designation covers Temab-A alone for adults with locally advanced or metastatic, EGFR wild-type, c-Met-expressing non-squamous disease after platinum chemotherapy and anti-PD-(L)1 therapy.
AbbVie is a large North Chicago drugmaker with oncology, immunology and neuroscience businesses. Temab-A is an investigational antibody-drug conjugate that pairs a c-Met-targeting antibody with a topoisomerase inhibitor payload, a design intended to deliver the drug to cancer cells expressing that protein.
The FDA's program description says breakthrough status is for drugs with preliminary clinical evidence suggesting substantial improvement on a clinically significant endpoint. It makes the company eligible for intensive agency guidance, senior FDA attention and Fast Track features. Temab-A remains unapproved for both uses, and a marketing application and review deadline would be separate steps.
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AbbVie's Trial Arms Cover Both Designated Uses
AbbVie said the designations were based mainly on its M21-404 first-in-human study. The ClinicalTrials.gov record, last updated Oct. 29, 2025, lists 520 participants across all arms, with Temab-A monotherapy arms in lung cancer and bevacizumab combination arms in colorectal cancer. That total is not the number treated in either designated subgroup.
The registered primary outcome is objective response rate. AbbVie's Oct. 7 release does not give response rates for the designated cohorts, a comparison against control, a p value, a confidence interval or a safety breakdown. Investors therefore have the FDA's designation but no detailed efficacy or tolerability table for the two requested uses in this announcement.
"These Breakthrough Therapy Designations reflect the growing clinical evidence supporting c-Met as a meaningful therapeutic target across multiple solid tumors," AbbVie vice-president of oncology early development Eleni Lagkadinou said in the Oct. 7 release.
A ClinicalTrials.gov study list shows a planned 990-patient colorectal comparison of Temab-A plus bevacizumab against bevacizumab with trifluridine/tipiracil. Its record, updated Oct. 7, lists the study as recruiting and estimates primary completion in May 2029. A separate lung comparison plans 660 patients against standard of care; its Oct. 5 update listed it as not yet recruiting, with primary completion estimated for March 2030.
Those enrolment figures are targets, rather than results. FDA guidance could shape the evidence AbbVie gathers from both comparisons, but the designations do not themselves change the registry's estimated completion dates.
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AstraZeneca's Approved Lung ADC Serves Another Biomarker Group
AstraZeneca PLC LONAZN NYSEAZN reported in a June 23, 2025 release that the FDA had granted accelerated approval to its antibody-drug conjugate Datroway for previously treated EGFR-mutated non-small cell lung cancer. Temab-A's lung designation instead concerns EGFR wild-type disease and a c-Met-expressing tumor, so Datroway's reported responses are not a proxy for Temab-A's.
AstraZeneca's release says Datroway had earlier received Breakthrough Therapy designation and that continued approval may depend on a confirmatory trial. The AstraZeneca precedent keeps designation and approval as separate regulatory milestones; AbbVie's Oct. 7 release gives no application date.
The next listed primary-completion estimate is Dec. 2026 for NCT06107413, a separate colorectal combination study. Its endpoint assessment will test another Temab-A regimen while the designated colorectal and lung comparisons continue toward their later completion dates.
