Uploaded by FinancialNewsOnline on Nov 18, 2011
FDA Commissioner Margaret Hamburg, M.D., said today she is revoking the agency's approval of the breast cancer indication for Roche's (NASDAQ:RHHBY) Avastin after concluding that the drug has not been shown to be safe and effective for that use.
The commissioner said, "After reviewing the available studies. It is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth that would justify those risks. Nor is there evidence that use of Avastin will help them live longer or improve their quality of life."
Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer.
The commissioner said, "After reviewing the available studies. It is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth that would justify those risks. Nor is there evidence that use of Avastin will help them live longer or improve their quality of life."
Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer.
