Thursday, Genentech, a unit of Swiss drugmaker Roche Holding AG (RHHBY.PK) announced that it has been notified of the Food and Drug Administration's proposal to revoke marketing approval of Avastin for treatment of breast cancer in combination with paclitaxel.
Avastin is a unique cancer drug that works by choking off the blood supply that is essential for the growth of tumor and its spread throughout the body. The drug secured its first FDA approval in 2004 for the treatment of metastatic cancer of the colon or rectum. It has subsequently been approved to treat non-squamous, non-small cell lung cancer, metastatic breast cancer, kidney cancer and brain cancer.
It was only an accelerated approval that Avastin was granted for the breast cancer indication in 2008. The accelerated approval program of FDA allows life-saving drugs to be approved based on less than traditionally required clinical data.
The companies that get their drugs approved under the accelerated approval program are required to conduct more studies demonstrating the long-term effectiveness and then seek regular approval. Roche was also asked to conduct two follow-up studies in order for Avastin to be given full approval for the breast cancer indication. But in the follow-up studies, the results were not as robust as the initial study since the drug delayed the growth of tumors only by one month to three months.
The FDA's decision does not impact Avastin's availability for its approved uses for other cancer types in the United States. An FDA Advisory Committee, which met in July, had also recommended revoking the approval of Avastin for breast cancer saying that the drug's progression-free survival advantages are not clinically meaningful.
Genentech announced that it will request a hearing with the FDA under the NOOH (Notice of Opportunity for a Hearing) issued to it. An NOOH is the mechanism FDA uses to provide a company an opportunity for a hearing on a proposal to withdraw an indication. Until the conclusion of the proceedings, Avastin remains FDA-approved for breast cancer, the company said.
As much as $88,000 is charged annually for an Avastin breast cancer regimen. Even if the approval for breast cancer is revoked, Avastin is likely to be prescribed "off-label" by doctors but insurance companies may stop paying for its use in breast cancer. Avastin generated annual revenue of 6.22 billion Swiss francs and accounted for 13% of Roche's total sales in 2009. According to analysts, Roche might lose 500 million francs to 1.5 billion Swiss francs of Avastin sales to treat breast cancer if the approval is revoked.
However, in the European Union, Avastin has been confirmed as a valuable treatment option in combination with paclitaxel for breast cancer by the EMA (European Medicines Agency).
Genentech added that the CHMP (Committee for Medicinal Products for Human Use) , which is part of EMA, recommended the removal of the combination of Avastin with docetaxel from the label based on uncertainty about the benefit of the combination and also recommended against a label extension with capecitabine. A final decision on the recommendations will be issued by the European Commission in due course.
RHHBY.PK closed Thursday's trading at $36.25, down 0.41% on a volume of 2.32 million shares.
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