CHMP recommends expanded approval of Sprycel to include the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) ALL.- BMS

Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the expanded approval of Sprycel (dasatinib), in combination with chemotherapy, to include the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

The positive opinion includes the tablet form of Sprycel and the powder for oral suspension formulation, which was first approved by the European Commission (EC) in July 2018, making Sprycel the only tyrosine kinase inhibitor with a formulation developed for administration in pediatric patients and patients who cannot swallow tablets. The CHMP recommendation will now be reviewed by the EC, which has the authority to approve medicines for the European Union (EU).