"The coalition applauds the FDA and Commissioner Margaret Hamburg for the decision to revoke the approval of Avastin (bevacizumab) in the first-line treatment of metastatic breast cancer. We understand the devastation of metastatic breast cancer and the fact that we do no know how to prevent or cure it. We remain committed to and focused on finding those answers.
Since 2008, NBCC has taken the position that accelerated approval for Avastin was lowering the bar on drug approval. Based on the results of randomized clinical trials, there is no evidence the drug extends the lives of breast cancer patients; evidence indicates that it does increase the risk of harm.
We are gratified that the FDA has continued to support science and put what is best for patients above political, public and industry pressures. The FDA's mission is to protect and promote the public's health. The goal of drug approval is to make available drugs that save lives, that significantly extend survival while maintaining a good quality of life.
If meaningful benefit for patients cannot be established, approval must not be granted. If evidence shows an approved drug has little or no benefit and harms patients, approval must be revoked. The decision on Avastin supports patients' trust that the drugs they are given have been proven to give them benefit and not expose them to greater harm. We must continue the search for interventions that do provide meaningful benefit that outweighs harm for women with breast cancer."
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