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To the Editor: Recently, the Food and Drug Administration (FDA) held an administrative hearing regarding the proposal to withdraw accelerated approval from Avastin (bevacizumab) for metastatic breast cancer. I served as a member of the Oncologic Drugs Advisory Committee (ODAC) at that meeting. Two recent online Perspective articles, by Carpenter et al.1 and D'Agostino,2 addressed the use of surrogate end points and the regulatory and political issues surrounding this hearing. But neither article covered a basic, patient-focused theme that we, the oncologists on the panel, considered: that of giving hope — but not false hope. Avastin received accelerated approval from . . .
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Mikkael A. Sekeres (2011) studied this question.
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