FDA cancer drug approval rate reviewed in JNCI

The FDA’s Office of Oncology Drug Products approved 53 new indications for the use of oncology and hematology drugs and biologics from July 2005 to the end of 2007. These included 18 new drug approvals and 35 additional indications for already approved drugs. Approval data from July 1, 2005 through Dec. 31, 2007 were reviewed for the FDA’s retrospective analysis, which 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/.

This review of approval data began 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.

For more information visit www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm.