Neo dos and don'ts

Although an FDA panel overwhelmingly backed Genentech Inc.'s Perjeta pertuzumab for neoadjuvant breast cancer, both the panel and FDA made clear the mAb is a unique case and any new drug that comes after it should not do as Genentech did - using a six-year-old trial that wasn't designed at the outset to meet the agency's new guidelines for neoadjuvant treatment.

Despite its near unanimous vote, the Oncologic Drugs Advisory Committee found plenty wrong with the pivotal Phase II NEOSPHERE trial of Perjeta, including the lack of blinding on the primary endpoint and the use of an unconventional chemotherapy regimen as background therapy in all arms of the trial...