AbbVie’s Temab‑A receives two FDA Breakthrough Therapy Designations for colorectal and lung cancer
The U.S. Food and Drug Administration granted Breakthrough Therapy Designations to AbbVie’s investigational ADC telisotuzumab adizutecan (Temab‑A) for two indications: refractory metastatic colorectal cancer in combination with bevacizumab, and EGFR‑wild‑type, c‑Met‑expressing non‑small‑cell lung cancer as monotherapy. Both designations rely on data from the first‑in‑human study M21‑404. AbbVie said the designations underscore the clinical promise of c‑Met targeting across solid tumours.
Why it matters
The designations allow AbbVie to receive intensive FDA guidance and Fast Track support, which can speed up clinical development and regulatory review, according to the company’s statement.
Key facts
- 1The FDA granted a Breakthrough Therapy Designation for Temab‑A combined with bevacizumab in adults with refractory metastatic colorectal cancer who have previously received fluoropyrimidine, irinotecan, oxaliplatin, anti‑VEGF therapy and, when indicated, anti‑EGFR therapy. news.abbvie.com
- 2The FDA granted a Breakthrough Therapy Designation for Temab‑A as monotherapy in adults with locally advanced or metastatic EGFR‑wild‑type, c‑Met‑expressing non‑squamous NSCLC who have previously received platinum‑based chemotherapy and an anti‑PD‑(L)1 antibody. news.abbvie.com
- 3Both designations were based primarily on results from the first‑in‑human study M21‑404 (NCT05029882). news.abbvie.com
- 4Temab‑A is an investigational antibody‑drug conjugate that targets the c‑Met protein and carries a topoisomerase 1 inhibitor payload. news.abbvie.com
- 5The ClinicalTrials.gov record for the study lists 520 participants across all arms, with planned 990‑patient colorectal and 660‑patient lung comparisons. mugglehead.com
Summary written by AlphAI from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.