Roche poised for Avastin showdown at FDA

Supporters of Genentech's cancer drug Avastin are rallying as the FDA prepares to reconsider its recommendation to pull the drug's indication for breast cancer. Approved on the agency's fast-track program, the breast cancer use came under scrutiny late last year, when required follow-up trials came back with less-than-stellar data.

Based on that data--which suggested that, on average, Avastin did not extend patients' lives--the FDA's expert advisors voted to rescind the breast cancer indication, leaving the drug approved for other cancers, and theoretically available for off-label use in breast cancer patients. FDA officials took that committee's advice. Cue loud protest from patients and politicians, worried that off-label use wouldn't be paid for by private insurers, not to mention Medicare. Roche asked the FDA to consider an appeal.

So, beginning tomorrow, the company will make a final effort to persuade agency officials that Avastin deserves to keep its breast cancer indication. Genentech stresses that the follow-up research did show Avastin held off tumor growth in patients with advanced breast cancer, improving their quality of life. "We looked at metastatic cancer, where almost everyone will have a recurrence of their disease," Dr. Philippe Bishop, head of global clinical development for Avastin, told Reuters. "We look for how long a patient can live without their disease getting worse."

Complicating matters is Avastin's high cost. It's a complex biological drug, and treatment can cost $8,000 per month. Politicians and some patients charge that the FDA's move to revoke the breast cancer indication was motivated by that number. And of course, the worry about insurance reimbursement for off-label use wouldn't be so acute if the average patient could afford to pay for Avastin out of pocket. The FDA says cost isn't the issue; it's the science.

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