FDA to Determine Avastin's Fate

On Tuesday, an FDA panel will consider whether or not Genentech/Roche should remove the indicator recommending Avastin as a viable breast cancer treatment.    The drug is also used to treat colon, lung and kidney cancer.

According to a briefing on the FDA website, the agency is going to look at whether or not initial studies presented as part of an accelerated approval bid requested by the company has been supported by subsequent research.

The FDA does allow some drugs to become approved before all studies have been submitted if initial research shows enough promise.  Pharmaceuticals then must agree to submit later study results in order for approval to be expanded.

According to the Wall Street Journal, Avastin was first accepted for accelerated approval to treat breast cancer in conjunction with chemotherapy back in 2008, despite a special panel’s 5-4 decision against the move. 

At a meeting of the FDA’s oncology drug committee on July 20, information on subsequent research after 2008 will be presented to determine whether or not the drug significantly extends the length of time before the disease becomes worse.  Initially, one particular study showed that the drug used in tandem with chemo added 5.5 months to median aggression survival when compared to the survival rates of those who solely underwent chemotherapy.

The FDA is now questioning that study since other research has shown the drug only extends the time before the cancer worsens by 1-2.9 months.  The agency must now determine whether or not “clinical benefit” has been sufficiently demonstrated and if that benefit outweighs the drug’s side effects, which include bleeding.

Avastin is Roche’s top selling cancer drug, bringing in revenue of $6 billion dollars annually.  Analysts tell the Wall Street Journal that removing the indicator for breast cancer could reduce sales by $1 billion. 
 
Avastin works by inhibiting tumor growth through interference with a protein that allows blood vessels to grow inside of a cancerous mass.