The U.S. Food and Drug Administration announced Thursday the approval of a new indication for Sprycel-dasatinib marketed by Bristol-Myers Squibb Company (BMY).
The new indication is for the treatment of a rare blood cancer when it is first diagnosed. Philadelphia chromosome positive chronic phase chronic myeloid leukemia or 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 blood cells.
Other FDA-approved drugs to treat various forms of CML include Gleevec, approved in May 2001, and Tasigna-nilotinib, approved in October 2007.
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 or imatinib. The agency converted Sprycel to a regular approval in May 2009.
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