following a full submission:
nilotinib 150mg hard capsules (Tasigna®) is accepted for use within NHS Scotland.
Indication under review: for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase.
First-line treatment with nilotinib in newly diagnosed patients has resulted in significantly higher molecular and cytogenetic response rates compared to the standard tyrosine kinase inhibitor. Further longer term follow-up data are needed to confirm the duration of this response and assess the impact on disease progression and overall survival.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of nilotinib. This SMC advice is contingent upon the continuing availability of the PAS in NHS Scotland.
|Drug Name:||nilotinib (Tasigna)|
|SMC Drug ID:||709/11|
|Manufacturer:||Novartis Pharmaceuticals UK Ltd|
|Indication:||For the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase.|
|Sub Category:||8.1 Cytotoxic drugs|
|Submission Type:||Full submission|
|Date Advice Published:||8 August 2011|