Bristol-Myers Squibb and Otsuka America Pharmaceutical, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved an update to the Sprycel® (dasatinib) product labeling. The labeling now includes five-year efficacy and safety data in adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) and seven-year data in CP Ph+ CML patients who are resistant or intolerant to prior therapy, including Gleevec® (imatinib mesylate).
Sprycel is associated with the following warnings and precautions: myelosuppression, bleeding-related events, fluid retention, cardiovascular events, pulmonary arterial hypertension, QT prolongation, severe dermatologic reactions, tumor lysis syndrome, and embryo-fetal toxicity. Please see detailed Important Safety Information below.
CML is a type of leukemia in which the body produces an uncontrolled number of abnormal white blood cells. According to the most recent statistics, about 33,990 people are living with the disease in the United States. An estimated 6,660 new cases were diagnosed in 2014. CML occurs when pieces of two different chromosomes (chromosomes 9, 22) break off and attach to each other. The newly formed chromosome is called the Philadelphia chromosome, which contains an abnormal gene called the BCR-ABL gene. This gene produces the BCR-ABL protein that signals cells to make too many white blood cells. There is no known cause for the genetic change that results in CML.
Sprycel was first approved by the FDA in 2006 for the treatment of adults with CP Ph+ CML who are resistant or intolerant to prior therapy including imatinib. At that time, Sprycel was also approved for adults with Ph+ ALL who are resistant or intolerant to prior therapy. It is the first and only BCR-ABL kinase inhibitor with survival data in its label for CP Ph+ CML patients who are resistant or intolerant to imatinib.
