Basic Information
Sprycel
Regulatory Information
EMEA/H/C/000709
November 20, 2006
September 21, 2006
44
May 24, 2024
Company Information
Ireland
Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867
Bristol-Myers Squibb Pharma EEIG
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Sprycel is indicated for the treatment of paediatric patients with: - newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML CP) or Ph+ CML CP resistant or intolerant to prior therapy including imatinib. - newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy. Sprycel is indicated for the treatment of adult patients with: - newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase; - chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate; - Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Sprycel is indicated for the treatment of paediatric patients with: - newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.
Overview Summary
Sprycel is a cancer medicine. It is used to treat adults with the following types of leukaemia (cancer of the white blood cells): - chronic myeloid leukaemia (CML) in the ‘chronic’ phase in newly diagnosed patients who are ‘Philadelphia chromosome positive’ (Ph+). In CML, granulocytes (a type of white blood cell) start growing out of control. Ph+ means that some of the patient’s genes have rearranged themselves to form a special chromosome called the Philadelphia chromosome which produces an enzyme, Bcr-Abl kinase that leads to the development of leukaemia. - CML in ‘chronic’, ‘accelerated’ and ‘blast’ phases. Sprycel is used when other treatments including imatinib (another cancer medicine) do not work or cause troublesome side effects; - Ph+ acute lymphoblastic leukaemia (ALL), where lymphocytes (another type of white blood cell) multiply too quickly, or in ‘lymphoid blast’ CML. Sprycel is used when other treatments do not work or cause troublesome side effects. Sprycel is also used in children to treat: - newly diagnosed Ph+ CML in the ‘chronic’ phase, or Ph+ CML when other treatments including imatinib cannot be given or have not worked; - newly diagnosed Ph+ ALL in combination with chemotherapy (cancer medicines). Sprycel contains the active substance dasatinib.