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Avastin and FDA/CMS Coordination: Genentech's Safe Strategy to Save Medicare Coverage

This article was originally published in RPM Report

Executive Summary

FDA’s June Avastin hearing featured a number of points of clear disconnect between the sponsor, the agency, and other stakeholders debating the role of the therapy for metastatic breast cancer. Perhaps the biggest: the most important issue may depend on a completely different agency, CMS.

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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.

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.

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

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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