EC follows FDA with new pediatric Sprycel approval

11 February 2019

Sprycel (dasatinib) will now become available in the European Union in combination with chemotherapy for the treatment of pediatric patients with newly-diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

The tyrosine kinase inhibitor (TKI) from Bristol-Myers Squibb (NYSE: BMY) was approved by the US Food and Drug Administration in this indication last month.

This is the second pediatric leukemia indication for Sprycel in Europe. The approval includes both the tablet form and, in a first for pediatric patients with ALL in Europe, the powder for oral suspension (PFOS) formulation of Sprycel.

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