EC approves expanded indication for Sprycel

6 July 2018

There was good news for US pharma major Bristol-Myers Squibb (NYSE: BMY) yesterday, with an expanded approval for its already blockbuster blood cancer drug Sprycel (dasatinib) in Europe.

The European Commission (EC) has expanded the indication for Sprycelto include the treatment of children and adolescents aged one year to 18 years with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP), and to include a powder for oral suspension formulation.

The approval follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use on April 26, 2018, and makes Sprycel the first ever tyrosine kinase inhibitor to be approved in a powder formulation for administration in pediatric patients and patients who cannot swallow tablets.

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