Bevacizumab [Avastin]: Process for Removal of Breast Cancer Indication Begun Because of Lack of Efficacy

Last Updated on December 19, 2010 by Joseph Gut – thasso

December 16, 2010  –  Today, the American Food and Drug Administration notified healthcare professionals and patients that it is recommending removing the breast cancer indication for Bevacizumab [Avastin] because the drug has not been shown to be safe and effective for that use. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.

Background:

The Food and Drug Administration (FDA) is making this recommendation after reviewing the results of four clinical studies of Bevacizumab [Avastin] in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. None of the studies demonstrated that patients receiving Bevacizumab [Avastin] lived longer and patients receiving Bevacizumab [Avastin] experienced a significant increase in serious side effects. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

Recommendation:

Oncologists currently treating patients with Bevacizumab [Avastin] for metastatic breast cancer should use their medical judgment when deciding whether a patient should continue treatment with the drug or consider other therapeutic options.

Patients currently receiving Avastin for breast cancer should speak with their oncologists about whether to continue their treatment or explore other treatment options.

More Information:

[12/16/2010 – News Release – FDA]
[12/16/2010 – Questions and Answers about Avastin – FDA]
[12/15/2010 – Avastin Decision Memo (PDF – 125KB) – FDA]

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Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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