BioCentury on BioBusiness,
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.
words displayed of
To read this article, you must be an Archives subscriber. Please choose one of the options below.
All contents Copyright © 1993-2017 BioCentury Publications, Inc. ALL RIGHTS RESERVED. All use of this Web Site and its contents is governed by the BioCentury User Agreement
. The contents of this Web Site are protected under U.S. and foreign copyright and intellectual property laws, and no part of this Web Site or its contents may be photocopied, reproduced or retransmitted in any form without the written consent of BioCentury, which may be requested from Reprints/Permissions
. BioCentury®; The Bernstein Report on BioBusiness™; The BioCentury 100™; The Clear Route to ROI™; Because Real Intelligence is Hard to Find™; BCIQ™; and BioPharma's Knowledge Center™; are trademarks of BioCentury Publications, Inc., P.O. Box 1246, San Carlos, CA 94070. SciBX® and SciBX: Science-Business eXchange® are trademarks of Nature America, Inc. that are jointly used by BioCentury Publications, Inc. and Nature America, Inc.
Whether you want an individual subscription or need a global group license, we have the products,
the experience and the customer support that biopharma executives, researchers, investors, service providers,
and industry stakeholders have trusted for nearly two decades.
Let our Subscriber Services team customize the best intelligence package available in the industry to meet your needs.
Free Trial Subscription 4 Weeks of Access
BioCentury's Weekly Business Intelligence Journal
Get a 4-week free trial subscription to BioCentury.
Get 4 Weeks Free
Thanks for purchasing this article.
Please bookmark this url for future reference.
We have also sent you a confirming e-mail with a receipt and this same url for your
close [ X ]