FDA Approved 88% of Cancer Drug Applications Since 2005

From The Cancer Letter, July 3, 2008:

Conventional wisdom: Fixated on safety and guided by belief that cancer drugs must extend survival, FDA has erected insurmountable barriers to innovation in oncology, causing drug companies to abandon the field.

The agency’s approval data in oncology points to a different picture: The FDA Office of Oncology Drug Products cancer division approved 53 new indications and declined to approve five. Another two applications were withdrawn by the sponsors.

Spanning the period between July 2005, when the office was created, through December 2007, this tabulation shows that the agency’s approval rate in oncology stands at 88.3 percent.

Click on The Cancer Letter Archive at left to download the July 3 issue (subscription or day pass required). Related documents for this story posted under Special Reports.
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tags: FDA|  drug development