Tuesday, July 5, 2011

Side effects of Avastin stops its usage in breast cancer

FDA advisory panel voted on 29th June to stop the usage of Avastin to treat metastatic breast cancer. Avastin is the best selling cancer drug in the world which was approved by the FDA to treat cancers (colon and rectal) that have spread to other body parts. FDA withdraws the usage due to lack of effectiveness and concerns about side effects of the drug. Avastin is also used to treat certain lung cancers. Avastin is manufactured by Genentech unit of Roche.

FDA oncology drug panel’s 6 members voted against the use of Avastin in breast cancer. As per advisory committee, Avastin was not helping women but exposing them to dangerous side effects like high blood pressure, heart attacks, gastrointestinal perforations, and hemorrhaging. With the support of the advisory panel FDA announced to withdraw Avastin's approval in breast cancer. FDA commissioner, Dr. Margaret Hamburg has made the decision. Patients in the audience started shouting against the FDA and its panelists after the voting.

The FDA decision came at the end of a 2 day hearing granted to Genentech. Though the approval is withdrawn doctors can recommend Avastin "off label" in breast cancer. Avastin is FDA-approved for cancers such as colon, kidney, lung, and brain. After this decision many insurance companies may not pay for its use in the treatment of breast cancer that can cost as much as $100,000 per year. Roche can drop up to $1 billion in revenue for Avastin, which creates more than $6 billion per year.

In 2008, FDA approved Avastin for the treatment of metastatic HER2-Negative Breast Cancer in combination with the chemotherapy drug Taxol. Avastin stops the blood vessels’ development to the cancerous tumors by acting as an antiangiogenic agent, which is considered to slow down the tumors' growth. In Europe, Avastin still remains on the market for breast cancer as European Commission approved the drug for broader use paired with Roche’s Xeloda for people suffering from metastatic breast tumors who aren’t suited to other chemotherapy options.

Video of FDA Panel Nixes Bevacizumab for Breast Cancer from youtube:


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