FDA plans to rescind approval of Avastin for breast cancer...but why?

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The FDA yesterday announced that it would be withdrawing approval for treatment of advanced stage breast cancer with the drug bevacizumab, which is known by the trade name Avastin. The FDA took this action as the drug has not been shown on average to improve outcomes for patients with advanced breast cancer.

However, ACSH’s Susan Ingber observes that the drug has been shown to have “significant benefit for some sub-populations of breast cancer victims.” With the forthcoming FDA action, those patients currently taking the drug would likely lose insurance coverage to pay for it. Since the out-of-pocket cost of the drug is in excess of $60,000 per year, ACSH's Dr. Gilbert Ross says, “If I were a woman receiving Avastin, and I were doing well on it, I’d probably be organizing a fundraiser for myself right now. While the FDA denies that cost-benefit concerns were considered, that is clearly not the case. Stay tuned for more cost-cutting decisions posing as public health measures — rationing by other names.”

Coincident with the FDA announcement, European Union regulators declared that they would instead limit the number of types of breast cancer for which the drug would have approval.