CHMP recommends extension to indication for Sprycel in Ph+ chronic myeloid leukemia.- BMS.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending changes to the terms of the marketing authorisation for Sprycel (dasatinib), from Bristol-Myers Squibb in chronic myeloid leukemia. The CHMP recommended approval of a new formulation, a powder for oral suspension, for use in paediatric patients and adopted an extension to the existing indication as follows: Sprycel is indicated for the treatment of paediatric patients with: newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (Ph+ CML -CP) or Ph+ CML -CP resistant or intolerant to prior therapy including imatinib.