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

This article was originally published in RPM Report

Executive Summary

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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