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FDA Cancer Drug Approval Rate Highlighted in JNCI
Date:2/18/2010

The FDA's retrospective analysis appears in the Feb. 24, 2010, issue of the Journal of the National Cancer Institute. The journal article is available now at http://jnci.oxfordjournals.org.

Approval data from July 1, 2005 through Dec. 31, 2007 were reviewed by the authors for this analysis. This review was started after the formation of the Office of Oncology Drug Products and the implementation in 2007 of the Food and Drug Administration Amendments Act (FDAAA). The review included indications for both conventional oncology drugs and biological oncology products reviewed in CDER. It did not include products reviewed in other FDA centers.

"The FDA used a variety of trial designs and endpoints in approving these applications. In addition, we implemented recent regulatory initiatives including accelerated approval and priority reviews to expedite the approval of these indications," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products, and one of the review's co-authors.


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