BioCentury on BioBusiness,
FDA's cancer drug initiative; Report card; The cancer initiative
Monday, March 31, 1997
WASHINGTON - The FDA's "reinvention" of cancer drug regulation, announced one year ago in a White House ceremony with President Clinton and top administration officials, has yielded discernable, but modest results, according to senior management of biotech companies that are developing cancer therapies. Their assessment is supported by top FDA officials, including Robert DeLap, director of the division of oncology drugs products (DODP) of the Center for Drug Evaluation and Research.
Although IND submissions increased last year over 1995 (see chart, A2), there is little hard data that either the agency or companies can point to as evidence of the initiative's impact. In the last year, FDA has granted accelerated approval for two cancer drugs whose applications predated the initiative: taxotere (docetaxel), approved in May 1996 for treatment of locally advanced or metastatic breast cancer in patients who have progressed or relapsed following doxorubicin therapy; and camptosar (irinotecan), approved in June 1996 for treatment with metastatic colorectal cancer in patients whose disease has progressed following standard chemotherapy.
In addition, other than accelerated approval, most of the provisions of the cancer initiative, including provisions related to supplemental indications, increased patient access to unapproved products and greater involvement of patients on advisory panels, have had little impact on biotech companies.
FDA report card
words displayed of
To read this article, you must be an Archives subscriber. Please choose one of the options below.
All contents Copyright © 1993-2016 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 ]