Roche announced that the FDA delayed a decision on whether to allow the company to continue to market Avastin (bevacizumab) as a first-line treatment for patients with advanced HER2-negative breast cancer. The extension was needed as the additional information provided by the company was "deemed a major amendment" by the agency, according to the drugmaker. The regulators are expected to issue a final decision by December 17.
The FDA granted accelerated approval for Avastin in this indication in 2008 based on studies suggesting it halted the progression of the disease for more than five months. However, two additional clinical studies failed to show benefit, and in July, an FDA advisory panel voted 12 to 1 in favour of recommending that the agency withdraw approval for the breast cancer indication.
Avastin had global sales of nearly $6 billion in 2010, and analysts estimate that if approval of the drug in the breast cancer indication were revoked, it could reduce sales by about $1 billion annually.
Reference Articles
Genentech provides update on Avastin for advanced breast cancer - (Genentech)
FDA delays decision on breast cancer drug Avastin - (MSN Money)
FDA delays decision on Avastin - (San Francisco Business Times)
FDA delays ruling on Avastin's use in advanced breast cancer (free preview) - (The Wall Street Journal)
**Published in "First Word"
No comments:
Post a Comment