Advice

in the absence of a submission from the holder of the marketing authorisation:

nilotinib (Tasigna®) is not recommended for use within NHS Scotland.

Indication under review:
• paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase
• paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting.  As a result we cannot recommend its use within NHSScotland.

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Medicine details

Medicine name:
nilotinib (Tasigna)
SMC ID:
1325/18
Indication:
In paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase. In paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib
Pharmaceutical company
Novartis Pharmaceuticals UK Ltd
BNF chapter
Malignant disease and immunosuppression
Submission type
Non submission
Status
Not recommended
Date advice published:
12 March 2018