'Morally Indefensible' Approval Standard Unchanged Despite Avastin Decision, WSJ Editorial Says

Main Category: Breast Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 28 Feb 2008 - 10:00 PST

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FDA has not changed its "morally indefensible standard" of how it balances risk and reward when approving drugs despite its approval last week of Genentech's cancer treatment Avastin for metastatic breast cancer treatment, a Wall Street Journal editorial says.

The agency's approval of Avastin as a breast cancer treatment should not have been "controversial," but it was because an FDA advisory panel ruled that "progression-free survival" was "not sufficient" for approval, according to the editorial. The agency's "usual" criteria of approving "anticancer agents" has been "extending life overall," but such guidelines "overlook the real benefits" drugs such as Avastin have for some women, the Journal says.

The "finality of life-and-death decisions makes the approval" of drugs such as Avastin "fundamentally a moral issue," the editorial says, concluding that "further drug approvals are still subject" to FDA standards that put "statistical models above the choices of dying patients" (Wall Street Journal, 2/27).

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