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Accelerated Withdrawal in Action: The Avastin Hearing Process

This article was originally published in RPM Report

Executive Summary

The June hearing on the status of Genentech’s metastatic breast cancer indication for Avastin will focus on a long list of substantive disagreements about the data. But any sponsor interested in the future of the accelerated approval process should study the back-and-forth in the hearing process itself.

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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.

Translating FDA for Investors: Seattle Genetics Shrugs Off Public Lambasting at ODAC

Actions speak louder than words. That, at least, is how Seattle Genetics urged investors to think about a tongue lashing the company received during an advisory committee review of the cancer agent Adcetris Seattle Genetics may be right on two levels: the practical outcome of the meeting was positive, and the FDA rhetoric may not have been as directly aimed at the sponsor as a warning to all oncology drug developers.

FDA's Avastin Breast Cancer Withdrawal Sets New Standard, Deters Drug Development

FDA’s proposal to withdraw the approval of Avastin for MBC is based on a new standard for the efficacy showing that a therapy must make in first-line MBC. The Agency previously -- and appropriately -- followed a more flexible approach based on data showing a medicine’s effect on PFS [progression-free survival] or other disease progression endpoints, together with data on OS [overall survival].

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