AbbVie's Temab-A receives two FDA Breakthrough Therapy Designations

The designations cover colorectal cancer and non-small cell lung cancer, and are the first for the drug.

GetSignal AbbVie Inc. ABBV

AbbVie said on October 7, 2026 that the U.S. Food and Drug Administration has granted two Breakthrough Therapy Designations for telisotuzumab adizutecan (Temab-A; ABBV-400) in colorectal cancer and non-small cell lung cancer.

The company said these are the first Breakthrough Therapy Designations for Temab-A and that its antibody-drug conjugate portfolio now includes four such designations. Temab-A is an investigational c-Met-directed antibody-drug conjugate with a novel topoisomerase 1 inhibitor, being studied in advanced solid tumors.

Key facts

Drug
Telisotuzumab adizutecan (Temab-A; ABBV-400)
Indications
Colorectal cancer; non-small cell lung cancer
Designations granted
Two
Portfolio total
Four Breakthrough Therapy Designations

All ABBV news

Source: The company's release on PR Newswire, October 7, 2026.

Written by GetSignal with AI from the company's press release.

Not investment advice.

Follow AbbVie on GetSignal

Its filings, insider trades and company news in one feed. Free on iPhone and Android.

Download on the App Store Get it on Google Play