Genentech’s Perjeta Gets FDA Panel Nod, But With “Some Words Of Advice”
This article was originally published in The Pink Sheet Daily
Executive Summary
Oncologic Drugs Advisory Committee members backing a claim for neoadjuvant treatment of early breast cancer cite pertuzumab’s special circumstances in cautioning that they are not opening the door wide to accelerated approval of other agents under an FDA draft guidance. And the panel chairman urges the company to “avoid a repeat performance of Avastin.”