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Genentech's Perjeta provides lessons for followers in neoadjuvant breast cancer
Neo dos and don'ts
Monday, September 16, 2013
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
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.
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