Project Confirm: Accelerated Drug Approvals for Chronic Myeloid Leukemia


 The Food and Drug Administration (FDA) has an accelerated approval program for drugs which have been identified as promising treatments for serious conditions when the available data suggests that the benefits outweigh the foreseeable risks. All of the currently available treatment options for chronic myeloid leukemia (CML) initially went through the accelerated approval program. Here a group of academic CML experts, patient panelists and members from the FDA convened to discuss the utility of the accelerated approval program as it pertains to CML, and the utility of this program in future drug development in this disease. The results of that discussion are summarized here.