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Never Again? Why the Avastin Hearing May Be One of a Kind

This article was originally published in RPM Report

Executive Summary

The two-day “streamlined withdrawal” hearing for Genentech’s breast cancer indication for Avastin was an unprecedented regulatory event. Based on how badly it went for the sponsor—and how uncomfortable it was for FDA—there may not be too many imitators any time soon.

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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.

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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