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AbbVie says FDA grants breakthrough therapy status for ABBV-400 in metastatic colorectal cancer

PUBT·10/07/2026 12:32:06
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AbbVie says FDA grants breakthrough therapy status for ABBV-400 in metastatic colorectal cancer
  • AbbVie won two FDA Breakthrough Therapy Designations for telisotuzumab adizutecan, an investigational c-Met-targeted antibody-drug conjugate.
  • Designations cover refractory metastatic colorectal cancer in combination with bevacizumab, alongside advanced c-Met-expressing non-squamous NSCLC as monotherapy.
  • Support came from outcomes in the first-in-human M21-404 study, with results already generated rather than pending presentation.
  • The FDA actions position the program for faster development, strengthening AbbVie’s next-generation oncology pipeline in biomarker-selected tumors.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. AbbVie Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: 202610070830PR_NEWS_USPR_____CG65114) on October 07, 2026, and is solely responsible for the information contained therein.