Product Liability

FDA considers risks, benefits of Avastin to treat breast cancer

avastin injection060622 100x100 FDA considers risks, benefits of Avastin to treat breast cancerThe risks and benefits of the top-selling cancer drug Avastin will be a hot topic for discussion at this week’s Food and Drug Administration (FDA) oncology drugs advisory committee meeting. The agency posted on its website that Roche Holding AG’s drug to treat several types of cancer including the most common type of advanced breast cancer may not be “clinically meaningful” to women and may put them at risk for serious side effects. The agency could decide to remove the breast-cancer indication for Avastin.

Avastin was the first drug to fight cancer by starving tumors of nutrients. Researchers hoped this “targeted therapy” would lead to the elimination of chemotherapy. However, it is now used in combination with chemotherapy.

Avastin is now approved to treat various cancers including colon, lung, kidney and brain. In 2008, Roche Holding AG received accelerated approval from the FDA to market Avastin for the treatment of the most common type of breast cancer in combination with the chemotherapy drug paciltaxel. This accelerated approval of the drug was based on initial positive studies despite a 5-4 vote by an advisory panel not to approve the drug without more evidence.

As part of the accelerated approval process, and to gain full approval for Avastin, data from two more studies was submitted to the FDA. Those studies did not confirm tumor shrinkage and showed significantly more side effects, such as high blood pressure, fatigue, bleeding, and abnormal white blood cell levels.

Avastin had global sales of nearly $6 billion last year. If the drug loses its indication for breast cancer treatment, analysts predict Roche Holding AG could lose about $1 billion in annual sales.