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AVASTIN approved for breast cancer: A tragedy
On 22 February 2008 Andrew von Eschenbach, MD, and Richard Pazdur, MD, director of the agency's Office of Oncology Drugs at the US Food and Drug Administration (FDA) approved the drug Avastin for the treatment of advanced breast cancer. This is a highly controversial decision because, while Avastin has been approved for colon and lung cancer, there is no evidence that it extends overall survival in breast cancer patients. In granting approval, the FDA rejected the recommendation of its advisory panel, the Oncology Drug Advisory Committee, which voted last December the drug, because the benefit in slowing tumour growth wasn't believed to be worth the added risk of serious side effects. Other prominent advocates in this field, including Breast Cancer Action and the National Breast Cancer Coalition, also argued forcefully against approval.
And not without good reason: 'disease-free survival' is not the same as overall survival. It simply means that, if you take Avastin, your cancer might not get any worse, but you will still die at approximately the same time as if you hadn't received Avastin.
And Avastin also boasts an impressive list of serious adverse side effects so, if you value your quality of life, you may well be better off not having it.
Pharmalot.com, a website devoted to pharmaceutical industry news and analysis, says 'the FDA's decision may now open the door for other cancer meds to be approved if studies find the meds can shrink tumors, although some docs worry patients may not really benefit.
Breast Cancer Action executive director Barbara Brenner says in a statement headlined 'Patients Lose, Genentech Wins.' 'The FDA has lowered the bar on the approval of breast cancer therapies. At a time when many questions are being raised about how the FDA approves drugs for market, today's decision is a victory for drug companies, but not for patients'. She recently wrote FDA leaders that any new drug approval for treatment should meet at least one of the following standards:
- Extend the life of the patient, i.e., improve overall survival, and/or
- Improve the patient's quality of life, and/or
- Cost less than therapies already available
Kay Dickersin, PhD, director of the Center for Clinical Trials at Johns Hopkins University, is quoted at the site as follows:
"If FDA sets a precedent of approving a drug based on progression free survival, people are afraid they may stop looking at survival as the most important endpoint."
"Standards short of these," she said, "put the interests of drug companies before those of patients and undermine the FDA's mission." The FDA's decision on Avastin, however, reflects the fact that "the agency's standards are dangerously different from these."
However, patient advocate, Margaret Kirk, president of Y-Me Breast Cancer Organization. disagrees. 'The benefits we're looking at with Avastin matter because they give patients hope . . . Without disease progression they may survive to see a discovery that can help them in the future.'
She should be realistic: If there is no useful drug now, another 5 months isn't going to produce one.
While 'Big Pharma' rules, 'alternative' cancer treatments which have shown much greater effectiveness than drugs such as Avastin, but are unpatentable, are routinely buried by the FDA and cancer industries. That's the real tragedy of this FDA decision.
