How To Withdraw A Drug: FDA’s Final Decision on Avastin
The “streamlined withdrawal” process for Avastin in metastatic breast cancer gave Genentech an extra 11 months to prepare for the transition to off-label status. It also gave FDA time to make preparations of its own.
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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.