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How to Withdraw a Drug: FDA’s Final Decision on Avastin

 
• By Laura Helbling

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.

It took almost exactly 11 months for FDA to finalize its decision to pull Roche /Genentech Inc. 's Avastin (bevacizumab) metastatic breast cancer indication.

Like everything else in the first-of-its-kind “streamlined withdrawal” process, that sets a precedent.

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