Roche to fight FDA’s decision on breast cancer drug

The world’s best selling cancer drug might lose its approval as a breast cancer treatment, but not without a fight.

Last week, the US Food and Drug Administration announced that it will remove the breast cancer indication from the label of Avastin. That was immediately followed by an announcement from the manufacturer – Genentech, a member of Swiss pharma giant Roche – with intentions to challenge the decision.

After reviewing the results of four clinical studies, the drug, the agency says, did not prove to be a safe and effective breast cancer treatment:

The data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

“I understand that today’s recommendation from the FDA is disappointing for patients with breast cancer,” says Richard Pazdur, head of the agency’s cancer drug division. “Please note that these findings are also disappointing for the FDA as well.”

Avastin (also known as bevacizumab) chokes off the tumor’s blood supply. And in combination with chemotherapy, it was approved in 2008 under an accelerated approval program – which allows a drug to be approved but requires further confirmation. (The program was intended to provide promising new drugs to patients while further trials are conducted.)

After the accelerated approval of Avastin for breast cancer, Genentech completed additional trials with results that the FDA thought weren’t evidence enough.

While the drug itself won’t be removed from the market (and the decision doesn’t affect its uses for colon, kidney, brain, and lung cancers), the move could still cost Genentech millions. And although doctors could continue to use it, insurers are less likely to pay for off-label use of the expensive drug. (Avastin could cost about $88,000 a year, though Roche caps costs at $57,000 for people earning under $100,000 a year.)

According to Genentech, the drug is used by about half of the 29,000 Americans receiving diagnoses of metastatic breast cancer each year. Last year, Avastin’s sales were nearly $6 billion, with about $855 million in the US alone.

The New York Times reports that the revocation could cost Roche from $500 million to $1 billion in lost sales.

Meanwhile, the European Medicines Agency (EMA), on the other hand, announced how it determined that Avastin together with the chemotherapy paclitaxel did provide modest benefits that outweighed the risks and “remains a valuable treatment option for patients suffering from metastatic breast cancer.”

The EMA’s confirmation didn’t go unnoticed. As Genentech chief medical officer Hal Barron says, “We believe women living in the United States with metastatic HER2-negative breast cancer should also have Avastin as a treatment option, and, therefore, we will request a hearing with the FDA.”

As the Wall Street Journal reports, that would mark the first time a company has challenged the FDA on such a decision.

Image: Genentech

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