nilotinib (Tasigna)

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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From January 2020, ADTCs may make formulary decisions on paediatric licence extensions for medicines previously accepted for use (or restricted use) for the corresponding indication in adults, taking account of relevant restrictions. This approach may also be applied retrospectively to medicines accepted for use in adults but not recommended in the corresponding indication in children due to absence of submission. PASAG liaises with companies to extend any PAS to include the younger age group and confirms arrangements with Boards.