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Bristol-Myers' blood cancer drug wins expanded approval in Europe


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Bristol-Myers' blood cancer drug wins expanded approval in Europe

Bristol-Myers Squibb Co. secured the European Commission's approval for its Sprycel drug to treat children and adolescents with a certain type of blood cancer.

Sprycel was previously approved to treat adults with Philadelphia chromosome-positive chronic myeloid leukemia, or CP-CML, in chronic phase, a type of blood cancer in which the bone marrow cells contain an abnormal chromosome, causing the body to produce too many white blood cells.

Bristol-Myers said the expanded approval also includes a powder formulation of the drug for patients who have difficulty swallowing tablets.

The EC's approval is backed by the results of CA180-226, a phase 2 trial which evaluated the drug, also called dasatinib, in children with CP-CML.

In November 2017, the U.S. Food and Drug Administration approved the expanded use of Sprycel to treat children.

The New York-based company noted that the tablet and powder for oral suspension formulations of Sprycel are not bioequivalents or the same.