FDA Delays Decision on Breast Cancer Drug

In a news release on Friday, Genentech, a division of Roche, announced that the Food and Drug Administration has its decision on whether or not to revoke its approval of Avastin for treating breast cancer by 90 days.  The Agency’s “verdict” is expected December 17.

The FDA granted advanced approval for the drug in 2008 based on data that patients given the drug showed an improvement in “progression free survival.”  Specifically, the information presented to the Agency showed that the drug lengthened by more than five months the time before the disease worsened in previously untreated HER2 –negative breast cancer.

In July, an advisory panel urged the FDA to rescind its approval of the drug, which in this case, means that approval would not be expanded.  Since the early 1990s, the FDA has had the authority to grant accelerated approval to drugs that show promise in treating serious disease.  In those instances, pharmaceuticals must agree to submit subsequent study results before expanded approval is granted.

Although the FDA typically follows the opinion of advisory panels, sometimes the agency goes ahead and acts on decisions contrary to panel recommendations.  That was the case in 2008, when another advisory panel voted 5-4 against Avastin’s bid for accelerated approval in treating metastatic breast cancer, in conjunction with other chemotherapy drugs.  The FDA voted to accelerate approval for the drug despite the panel’s decision.

In requisite follow up studies, Avastin hasn’t fared as well; subsequent research has shown that the drug extends the time before worsening by only one month, compared to chemotherapy alone.  The advisory panel to the FDA ultimately voted 12-1 to revoke approval, citing that the drug’s clinical benefits did not outweigh its side effects, which include bleeding.

Should the FDA decide to rescind approval, Avastin will still be used to treat colon, kidney, brain and colorectal cancer; it will also be available for off-label use to treat breast cancer. 
However, even though the drug could still be available for breast cancer, the cost to use it would be astronomical, and not likely covered by insurance.  According to the New York Times, the average cost of the drug per breast cancer patient is $88,000.

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.  The Swiss drug maker recently announced that they are considering lay-offs.