2005 Update On Accelerated Fda Approval Of Drugs Used To Treat Hematologic Malignancies From The Research On Adverse Drug-Events And Reports (Radar): Rate Of Regular Approval Conversion Remains Low.

Background: At ASH 2004 we reported that prior to 2004, eight drugs had received accelerated approval (AA) for ten hematologic oncology indications, only one had converted to full approval, and three serious adverse events associated with two of these drugs were identified post-approval. Following our presentation, Congressman Ed Markey (D-Massachussets) in June 2005 issued a report (“Conspiracy of Silence”) that raised similar concerns about the low rates of conversion from accelerated to regular approval and the failure of the FDA in ensuring that drug companies complete the required post-marketing studies. We update the experience with accelerated FDA approval for hematologic oncology.