The accelerated approval process in oncology : an examination of the conversion rate of approved therapies to full approval

In 1992, Accelerated Approval, or Subpart H approval, was added to the NDA regulations so promising products that provide a meaningful therapeutic benefit for serious or life-threatening diseases could be introduced to the market sooner, particularly for diseases or conditions where there was a great unmet medical need. Accelerated Approval is based on either a surrogate endpoint that is reasonably likely to predict clinical benefit or a clinical endpoint other than survival or irreversible morbidity. After approval, the sponsor is required to perform post-marketing studies to demonstrate clinical benefit. Since the FDA expanded the use of the Accelerated Approval regulatory path to include oncology drugs in 1995, thirty drugs (both small molecule as well as biologics) have been granted accelerated approval in oncology. However, from various reports in the literature and the FDA site, it appears that only a small fraction of these approvals (four to six) have been converted into regular approvals, based on the demonstration of clinical benefit in the post-marketing studies that support the benefit seen in the pivotal studies.

Department dc:contributor.department

Harvard University--MIT Division of Health Sciences and Technology.

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2006

Author dc:creator

• Kim, Jean Jinsun

Advisor dc:contributor.advisor

• Ernst R. Berndt and Frank L. Douglas.

• Harvard University--MIT Division of Health Sciences and Technology.

Statement dc:rights

• M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission.

Licence dc:rights.uri

• http://dspace.mit.edu/handle/1721.1/7582

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/1721.1/35553

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/35553