NICE technology appraisal guidance
Issued: January 2012
TA241

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

This is an extract from the guidance. The complete guidance is available at guidance.nice.org.uk/ta241

1 Guidance

This guidance should be read in conjunction with the following NICE guidance: NICE technology appraisal guidance 70 (TA70) Guidance on the use of imatinib for chronic myeloid leukaemia.

This guidance partially updates NICE technology appraisal guidance 70 (published October 2003).

For details see About this guidance.

1.1 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.

1.2 Dasatinib is not recommended for the treatment of chronic, accelerated or blast-crisis phase CML in adults with imatinib intolerance or whose CML is resistant to treatment with standard-dose imatinib.

1.3 High-dose imatinib[1] is not recommended for the treatment of chronic, accelerated or blast-crisis phase Philadelphia-chromosome-positive CML that is resistant to standard-dose imatinib.

1.4 People who are currently receiving dasatinib or high-dose imatinib for the treatment of CML should have the option to continue treatment until they and their clinicians consider it appropriate to stop.



[1] The summary of product characteristics (SPC) for imatinib states that the dose may be increased from 400 mg to 600 mg or 800 mg in patients with chronic phase disease, or from 600 mg to a maximum of 800 mg in patients with accelerated phase or blast crisis (see SPC for full details). High dose imatinib refers to doses of 600 mg or 800 mg in the chronic phase disease or 800 mg in the accelerated phase or blast crisis.