Gleevec (imatinib mesylate), a highly promising new drug for the treatment of 
chronic myelogenous leukemia in blast crisis, in accelerated phase, and in 
chronic phase after interferon failure or intolerance, received orphan drug 
status from the U.S. Food and Drug Administration (FDA) Office of Orphan 
Products Development on January 31, 2001, and accelerated approval from the FDA 
for the above three indications on May 10, 2001. The purpose of this report is 
to summarize FDA regulatory mechanisms, i.e., accelerated approval and orphan 
drug regulations, that have permitted patients to receive this drug as rapidly 
as possible.