Posted by Michael Wonder on 17 Dec 2018
Bristol-Myers Squibb receives positive CHMP opinion recommending Sprycel (dasatinib) for paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia
17 December 2018 - Bristol-Myers Squibb today announced that the CHMP of the EMA has recommended the expanded approval of Sprycel (dasatinib), in combination with chemotherapy, to include the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia.
The positive opinion includes the tablet form of Sprycel and the powder for oral suspension formulation, which was first approved by the European Commission in July 2018, making Sprycel the only tyrosine kinase inhibitor with a formulation developed for administration in paediatric 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.
The application is based on data from CA180-372 (NCT01460160), an ongoing Phase 2 trial evaluating the addition of Sprycel to a chemotherapy regimen modelled on a Berlin-Frankfurt-Munster high-risk backbone in paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphocytic leukaemia.
