Basic Information
Scemblix
Regulatory Information
EMEA/H/C/005605
August 25, 2022
June 23, 2022
11
May 21, 2025
Company Information
Ireland
Vista Building Elm Park Merrion Road Dublin 4
NOVARTIS EUROPHARM LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (Ph+ CML CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1).
Overview Summary
Scemblix is a cancer medicine. It is used to treat chronic myeloid leukaemia (CML), a cancer of the white blood cells, in the ‘chronic’ phase (this is when the condition is developing slowly and the patient has few or no symptoms). The medicine can be used in adult patients whose cancer is ‘Philadelphia‑chromosome positive’ (Ph+). Ph+ means that two of the patient’s chromosomes have rearranged themselves and formed a special chromosome called the Philadelphia chromosome. This chromosome produces an enzyme, BCR::ABL1 kinase, that leads to the development of leukaemia. Scemblix is used in patients who have already been treated with two or more cancer medicines called tyrosine kinase inhibitors. CML is rare, and Scemblix was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 24 March 2020.