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ODAC Split On Avastin Use In First-Line Metastatic Breast Cancer

Executive Summary

FDA's Oncologic Drugs Advisory Committee creates a second obstacle to the approval of Genentech's Avastin in metastatic breast cancer by deciding that existing data do not establish a positive risk-benefit profile for a first-line indication. Genentech's primary obstacle is relying on a surrogate endpoint for full approval, in trying to use progression-free survival as a direct measure of clinical benefit

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