Avastin’s Approval Revoked: Harvard Health Publications Uncovers The FDA’s Process
Last week, the FDA revoked its 2008 approval of the drug Avastin to treat breast cancer, concluding that the drug does little to help women with breast cancer while putting them at risk for potentially life-threatening side effects. Avastin will remain on the market (and so be potentially available to women with breast cancer) because it has also been approved to treat other types of cancer.
In a statement, FDA Commissioner Margaret A. Hamburg said this:
FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use. 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 either help them live longer or improve their quality of life.
Why does this happen? Read more »
*This blog post was originally published at Harvard Health Blog*
