Avastin Warning Labels Updated to Include Risk of Ovarian Failure

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In response to new information stating that Genetech’s best-selling cancer drug Avastin (bevacizumab) may affect fertility in some women, the U.S. Food & Drug Administration (FDA) has announced that it will be requiring warning labels of the drug to be updated to include information about the risk of ‘ovarian failure.’ The administration is advising doctors to counsel women of childbearing age about the possibility that taking Avastin could potentially cause their ovaries to stop releasing eggs prematurely. Avastin is currently the best-selling cancer drug in the United States, with annual sales of approximately $7 billion.

What’s the problem?

October 5, 2011 – The data leading up to the FDA’s decision to update the labels of Avastin came from a clinical trial involving 179 women with colon cancer who were being treated with chemotherapy (roughly half of whom also took Avastin). The study results found that nearly 35% of women from the Avastin group experienced ovarian failure, compared to just 2% of women receiving chemotherapy alone. Ovarian function returned in approximately 20% of the participants after discontinuing treatment with Avastin, but the long-term effects of the drug continue to remain largely uncertain.

Avastin is currently approved by the FDA to treat certain varieties of lung, brain, kidney, colon and breast cancers. However, in 2010, an independent advisory panel unanimously recommended that Avastin’s approval for breast cancer be revoked. The recommendation was based on data from four clinical trials that found the drug failed to extend the lives of metastatic breast cancer patients. Avastin did show the ability to delay the onset of the condition by one to three months, but at the risk of potentially life-threatening side effects.

It is important to note that the new update of Avastin’s warning label is a fundamentally different issue from the debate over its breast cancer approval. The FDA has still not decided on whether to revoke its approval for that purpose.

In other developments, Blue Shield of California has announced that it will no longer cover payments on Avastin when being used to treat breast cancer. With well over three million members, the company may be the largest insurer to drop such coverage. According to the New York Times:

Because it is an emotional and politically contentious issue, with some women
saying the drug is keeping them alive, many insurers have said they will wait until
a final decision from the F.D.A. before re-evaluating their coverage policies. And
Medicare has indicated it will continue paying for the drug even if the F.D.A.
revokes the approval.

But Blue Shield decided not to wait. In a note posted on its Web site, it said
reimbursement would end Oct. 17, though “exceptions may be considered on a
case-by-case basis.”

“We agreed with the F.D.A. panel,” Stephen M. Shivinsky, a spokesman for Blue
Shield, said on Friday. He said the insurer would continue to pay for the drug for
women who were already using it.

Regardless of whether the FDA revokes Avastin’s approval for the treatment of breast cancer, the drug will remain on the market indefinitely to treat the other forms of cancer for which it is approved. Avastin has enjoyed widespread success and is currently the country’s best-selling cancer medication, with annual sales topping $7 billion.

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