Legal News

The advisory committee for the FDA made its recommendation on July 19, regarding the cancer drug Avastin. The committee has found that the new research submitted on the drug indicates it has no appreciable benefits to patients with breast cancer and should not be promoted to treat that particular type of the disease. The committee finding would not affect the marketing or use of the drug for brain, lung, colon and kidney cancer.

The Los Angeles Times reports that Avastin, generic name bevacizumab, came onto the market after an "accelerated approval" process at the FDA for use in treating breast cancer in February, 2008. The accelerated approval process allows the FDA to rapidly approve drugs to treat life-threatening conditions, but also requires the drug manufacturer to provide additional post-market studies to confirm the drug's effectiveness and safety.

According to the Times, Avastin was combined with another drug, paclitaxel, to treat women with metastatic breast cancer. The initial trial showed an increase in the time during which the drug therapy prevented progression of the disease, known as progression-free survival, by a little over five months compared with paclitaxel alone.

However, new studies did not confirm the initial results. In fact, some studies showed the progression-free survival time increased by just over a month, with overall survival rates not increasing. Additionally, due to complications with the drug, the survival time was actually slightly less for some patients.

The Times confirms that the committee has voted 12-1 that the FDA should rescind marketing approval for use of Avastin in treating breast cancer. The drug's manufacturer, Genetech, says it stands by the findings presented in the initial study and in a statement said the drug, "should continue to be an option for patients with this incurable disease." Genetech is a subsidiary of Roche.

A decision on Avastin is expected before the end of September. Although the FDA is not bound to follow the recommendations of the committee, it usually does.

Related Resources:

• FDA Panel: Avastin Not for Breast Cancer (WebMD)
• Why Drugs Get Pulled from the Market (FindLaw)
• Center for Regulatory Effectiveness Calls for FDA Advisory Committee Independence (PR NewsWire, FindLaw)
• Panel: Avandia Should Remain on Market Despite Risks (FindLaw's Common Law)
• Drugs and Medical Devices - An Overview (provided by Blizzard, McCarthy & Nabers, LLP)
• Personal Injuries from Dangerous or Defective Products (provided by Briskman & Briskman)