FDA says NO to Avastin for breast cancer

Fda

Image via Wikipedia

 

America’s Food and Drug Agency

turns down Avastin appeal

 

In Washington, advisers to the Food and Drug Administration voted 6-0 to halt the use of cancer drug Avastin for the treatment of breast cancer.

They say studies have failed to show Avastin is effective for that purpose.

Makers Genetech had mustered a mass of testimonies from doctors and advocacy groups, and patients such as  Crystal Hanna, a mother of two who will celebrate her 36th birthday Friday.

“I’m a testament that the drug does work…I’m not just a statistic,” she said. “Keep breast cancer on the label so that I and others like me can celebrate more birthdays.”

This was a very hard-fought political battle, and Advisers acknowledged the emotional nature of the issue, but said  science should prevail. “I think we all wanted Avastin to succeed,” said Natalie Compagni-Portis, a member of the committee. “And yet what we have to do today is respond to the research that’s been presented to us…these studies didn’t bear out that hope.”

The drug will remain on the market for other cancer treatments, but the FDA’s withdrawal will likely mean insurance companies won’t cover it for breast cancer patients. As a result, many women won’t be able to afford the treatments, which can cost up to $100,000 a year.

Though the FDA will make the final decision, it rarely ignores recommendations of its advisers. One of the rare instances was in 2008, when the agency approved Avastin for breast cancer treatment for the first time. The decision came under the agency’s “accelerated approval” process, which fast-tracks potentially life-saving drugs on a conditional basis.

WASHINGTON…A panel of advisers to the Food and Drug Administration voted 6-0 to halt the use of cancer drug Avastin for the treatment of breast cancer, saying studies have failed to show Avastin is effective for that purpose.

The recommendation Wednesday came after two days of testimony from patients, doctors, and advocacy groups. The panel faced several tearful accounts, like that of Crystal Hanna, a mother of two who will celebrate her 36th birthday Friday. “I’m a testament that the drug does work…I’m not just a statistic,” she said. “Keep breast cancer on the label so that I and others like me can celebrate more birthdays.”

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Advisers acknowledged the emotional nature of the issue, but said the science should prevail. “I think we all wanted Avastin to succeed,” said Natalie Compagni-Portis, a member of the committee. “And yet what we have to do today is respond to the research that’s been presented to us…these studies didn’t bear out that hope.”

The drug will remain on the market for other cancer treatments, but the FDA’s withdrawal will likely mean insurance companies won’t cover it for breast cancer patients. As a result, many women won’t be able to afford the treatments, which can cost up to $100,000 a year.

Though the FDA will make the final decision, it rarely ignores recommendations of its advisers. One of the rare instances was in 2008, when the agency approved Avastin for breast cancer treatment for the first time. The decision came under the agency’s “accelerated approval” process, which fast-tracks potentially life-saving drugs on a conditional basis.

Approval was based on a single study by the manufacturer, which suggested the drug prevented the disease from advancing for an average of 5.5 months. But subsequent studies have failed to replicate the results, and have shown the drug carries serious risks like high blood pressure, heart attacks, and bleeding.

“We are very disappointed by the committee’s recommendation,” said Krysta Pellegrino, a spokesperson for Genentech, which is based in South San Francisco. The company has successfully marketed Avastin as a blockbuster drug for treating colon, lung, and brain cancers.

What next?

According to reports, approval was based on a single study by the manufacturer, which suggested the drug prevented the disease from advancing for an average of 5.5 months. But it was said that subsequent studies failed to replicate the results, and showed the drug can carry serious risks like high blood pressure, heart attacks, and bleeding.

In Britain, this might mean drug companies paying much more attention to keeping patients happy, instead of ignoring side effects that patients present.  With the new broom sweeping through the NHS, patients are going to be demanding value for money, and questioning if the sometimes horrendous side effects actually produce a compensating benefit to them, rather than the drug company’s profits.

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One thought on “FDA says NO to Avastin for breast cancer

  1. Irene July 1, 2011 at 10:28 pm Reply

    The phase III Clinical Trial I am on for Ramucirumab (IMC-1121B) is a fully human monoclonal antibody – hailed as the successor to Avastin.

    http://en.wikipedia.org/wiki/Ramucirumab
    ‘Ramucirumab is a fully-human monoclonal antibody (IgG1) directed against the Vascular Endothelial Growth Factor Receptor 2 (VEGFR2). By binding to the VEGF Receptor 2 it works as a receptor antagonist blocking the binding of vascular endothelial growth factor (VEGF) to its receptor (VEGF Receptor 2). VEGF Receptor 2 is known to mediate the majority of the downstream effects of VEGF in angiogenesis. Ramucirumab is being tested in several phase III clinical trials. [1]. ‘

    http://knol.google.com/k/ramucirumab-lilly-cancer-review#
    ‘Ramucirumab (Lilly) Cancer Review
    Monoclonal antibody mAbs ( Anti VEGF R2 KDR) for Gastric and Breast Cancer
    Ramucirumab if its passes safety and efficacy criteria in Phase III trials and approved by regulators in major market may turn out to be the next Avastin. The takeover of ImClone by Lilly 2 years ago added a potential blockbuster monoclonal antibody to its R&D portfolio. Avastin is the current top selling mAbs for cancer and remucirumab acts by the same mechanism and targets vascular endothelial cell growth factor receptor 2 EFGR2. A short review of Remucirumab, ImClone and Gastric cancer is presented and will be updated regularly’
    …..see website more detail

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