THURSDAY, June 29, 2006 (HealthDay News) -- Bristol-Myers Squibb's Sprycel (dasatinib) has received accelerated approval from the U.S. Food and Drug Administration to treat a rare cancer called chronic myeloid leukemia (CML).
CML, characterized by uncontrolled growth of white blood cells, affects about 4,600 people each year in the United States, the FDA said in a prepared statement. Sprycel was also approved to treat Philadelphia chromosome-positive acute lymphoblastic leukemia, a more serious form of the disease.
The drug is intended for people who cannot tolerate or are no longer responding to Gleevec, the standard therapy for people with these diseases. Bristol-Myers is conducting post-approval studies to demonstrate the drug's long-term effects and its potential to improve survival, the agency said.
In clinical testing, 45 percent of participants with early-stage CML who took Sprycel showed a significant reduction or elimination in detectable leukemia cells, the FDA said.
To learn more about CML, visit the American Cancer Society.