Perjeta, Avastin Breast Cancer Approvals Are A Study In Contrasts

Pertuzumab’s approval came almost a year after FDA and Genentech battled over the future of bevacizumab’s breast cancer claim at an unprecedented public hearing. While both oncologic agents were approved on the basis of a median progression-free survival benefit exceeding five months, the regulatory similarities end there.

What a difference a year makes.

In June 2011, Genentech Inc. and FDA’s Center for Drug Evaluation and Research were battling over the fate of...

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