Following a full submission
nilotinib (Tasigna) is accepted for restricted use within NHS Scotland for treatment of chronic phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib. It should be restricted to use in patients who are in the chronic phase of the disease.
The manufacturer has not made a submission for use in the accelerated phase. As a result we cannot recommend its use within NHSScotland.
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Medicine details
- Medicine name:
- nilotinib (Tasigna)
- SMC ID:
- 440/08
- Indication:
- For the treatment of adults with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML)
- Pharmaceutical company
- Novartis Pharmaceuticals UK Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Superseded
- Date advice published
- 09 June 2008
SMC advice was superseded by NICE MTA 241: Dasatinib, high-dose imatinib and nilotinib for the treatment of imatinib resistant chronic myeloid leukaemia (CML) (part review of NICE technology appraisal guidance 70), and dasatinib and nilotinib for people with CML for whom treatment with imatinib has failed because of intolerance (January 2012). This advised that nilotinib is recommended for the treatment of chronic or accelerated phase Philadelphia-chromosome-positive chronic myeloid leukaemia (CML) in adults: whose CML is resistant to treatment with standard-dose imatinib; or, who have imatinib intolerance; and, if the manufacturer makes nilotinib available with the discount agreed as part of the patient access scheme.
NICE MTA 241 was withdrawn in December 2016 but the NICE MTA 241 advice for nilotinib remains valid in NHSScotland.