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Avastin Loses Its Breast Cancer Claim; FDA’s Hamburg Opts For Withdrawal Over Restrictions

 
• By Sue Sutter

FDA Commissioner Margaret Hamburg says Genentech has failed to identify a subpopulation of patients in whom the clinical benefits outweigh the risks. The company says it will not appeal the indication’s withdrawal but will pursue a new study in breast cancer.

Avastin’s first-line metastatic breast cancer claim should be withdrawn, rather than merely restricted, because sponsor Genentech Inc. has failed to identify a subpopulation of women in whom the clinical benefits outweigh the VEGF-inhibitor’s risks, FDA Commissioner Margaret Hamburg has decided.

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