AbbVie’s Temab-A receives two FDA Breakthrough Therapy Designations in colorectal and lung cancer

AbbVie has received two Breakthrough Therapy Designations from the U.S. Food and Drug Administration for telisotuzumab adizutecan, also known as Temab-A or ABBV-400, in colorectal cancer and non-small cell lung cancer.

Temab-A is an investigational next-generation c-Met-directed antibody drug conjugate carrying a novel topoisomerase 1 inhibitor payload.

The first designation covers Temab-A in combination with bevacizumab for adults with refractory metastatic colorectal cancer who have previously received fluoropyrimidine, irinotecan, oxaliplatin and anti-VEGF therapy, as well as anti-EGFR treatment where appropriate.

The second designation applies to Temab-A as a monotherapy in adults with locally advanced or metastatic EGFR wild-type, c-Met protein-expressing, non-squamous non-small cell lung cancer.

Eligible patients in the NSCLC setting must previously have received platinum-based chemotherapy and an anti-PD-(L)1 antibody.

AbbVie said both designations were primarily supported by results from the first-in-human M21-404 study.

The designations are the first Breakthrough Therapy Designations awarded to Temab-A.

AbbVie said they also expand the number of Breakthrough Therapy Designations across its antibody drug conjugate portfolio to four.

Eleni Lagkadinou, MD, PhD, Vice President of Oncology Early Development at AbbVie, said the designations add to clinical evidence supporting c-Met as a therapeutic target across multiple solid tumours.

She said Temab-A has shown potential both as a monotherapy and in combination regimens and forms part of the company’s broader strategy to advance biomarker-driven cancer treatments.

Colorectal cancer and lung cancer together affect more than four million people worldwide each year and remain major causes of cancer-related mortality.

Despite advances in treatment, patients with refractory colorectal cancer and advanced non-small cell lung cancer may still experience disease progression, creating a need for additional therapeutic approaches.

The FDA’s Breakthrough Therapy Designation programme is intended to accelerate the development and review of investigational medicines that show preliminary clinical evidence of substantial improvement over available treatments on clinically important endpoints.

Temab-A remains investigational and has not been approved by regulatory authorities.

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Related Topics and Keywords

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