The U.S. Food and Drug Administration today approved a new indication for Sprycel (dasatinib) for
the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia
chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing
blood and bone marrow disease linked to a genetic abnormality.
Sprycel, an oral
kinase inhibitor, is believed to inhibit the activity of certain proteins responsible for the
growth of cancer cells. The action allows bone marrow to begin reproducing normal red and white
In June 2006, the FDA granted accelerated approval for Sprycel to treat
adults with CP-CML with resistant disease or who were intolerant to prior therapy, including
Gleevec (imatinib). The agency converted Sprycel to a regular approval in May 2009, after 24-month
follow-up data from earlier clinical studies confirmed the treatment’s safety and
Other FDA-approved drugs to treat various forms of CML include
Gleevec, approved in May 2001, and Tasigna (nilotinib), approved in October 2007.
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