FDA grants two breakthrough therapy designations to AbbVie’s telisotuzumab adizutecan
The U.S. Food and Drug Administration awarded breakthrough therapy designations for AbbVie’s investigational antibody‑drug conjugate telisotuzumab adizutecan. The designations cover refractory metastatic colorectal cancer combined with bevacizumab and EGFR‑wild‑type non‑small‑cell lung cancer as monotherapy. AbbVie’s vice‑president of oncology early development highlighted the designations as evidence of c‑Met’s therapeutic relevance. The news lifted AbbVie’s share price in after‑hours trading.
Why it matters
The designations could accelerate the drug’s development timeline, which may improve AbbVie’s pipeline value; the company’s stock rose 0.44% after‑hours and 2.42% over the past five days according to the reports.
Key facts
- 1The FDA granted two breakthrough therapy designations to telisotuzumab adizutecan. benzinga.com
- 2The first designation is for Temab‑A plus bevacizumab in adults with refractory metastatic colorectal cancer. benzinga.com
- 3The second designation is for monotherapy in EGFR wild‑type, c‑Met‑expressing, non‑squamous non‑small cell lung cancer. benzinga.com
- 4AbbVie’s vice president of oncology early development, Eleni Lagkadinou, said the designations reflect growing clinical evidence for c‑Met as a therapeutic target. benzinga.com
- 5Shares rose 0.44% in after‑hours trading to $272.56. benzinga.com
- 6AbbVie’s market capitalization is about $479.52 billion. benzinga.com
Summary written by AlphAI from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.