FDA Ruling On Avastin A 'Critical Test' For Agency, New York Times Editorial Says

Main Category: Breast Cancer
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 27 Jul 2010 - 2:00 PDT


The recent "flameout" of the breast cancer drug Avastin "will pose a critical test" on whether FDA will "have the courage to reverse course when a medical treatment that it approved based on preliminary evidence flops badly in follow-up studies," the New York Times says in an editorial.

In 2008, FDA granted Genetech's Avastin "accelerated approval" to treat breast cancers that have spread to other parts of the body. Such approval is a "hurry-up mechanism" that "allows approval of a drug that has not yet been proved safe and effective in thorough clinical trials but has shown promise that it might benefit patients with life-threatening diseases," the Times says. A single clinical trial showed that when used with another drug, Avastin could slow breast cancer's progression but "did not significantly extend patients' lives," the editorial says. "Now two follow-up trials by the manufacturer have failed to confirm even those meager gains," leading an FDA advisory committee to "quite sensibly" vote 12-1 last week in favor of revoking Avastin's approval as a breast cancer treatment, the Times says.

The Times argues that FDA "has rarely removed drugs that were given accelerated approval and sometimes has failed even to compel completion of follow-up studies." However, "there are signs it may get tougher," the editorial continues, concluding, "With Avastin, the follow-up studies were completed in a timely manner -- with such meager results that withdrawal seems the right response" (New York Times, 7/26).

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