TUESDAY, Dec. 9, 2003 (HealthDayNews) -- The U.S. Food and Drug Administration has granted formal approval to the anti-cancer drug Gleevec as a second-line treatment for a rare form of leukemia.
Chronic Myeloid Leukemia (CML) is a life-threatening form of the disease that affects about 40,000 people in the United States. The drug was granted conditional "accelerated approval" to treat CML in May 2001, and formal approval was dependent on further studies confirming its long-term benefit.
The agency's accelerated approval program makes drugs for life-threatening diseases available earlier in the development process -- before all the clinical data proving their long-term safety and effectiveness are ready.
As required by the original approval, Gleevec manufacturer Novartis Phamaceuticals continued following CML patients, 95 percent of whom wound up achieving normal white blood cell counts after two years of study, the FDA says.
For more information about Gleevec and CML, visit the FDA's Center for Drug Evaluation and Research.