Dasatinib, High-Dose Imatinib and Nilotinib for the Treatment of Imatinib-Resistant Chronic Myeloid Leukaemia (CML), and Dasatinib and Nilotinib for People with CML for Whom Treatment with Imatinib has Failed because of Intolerance (TA241)

Technology Appraisal Guidance No. 241

Source: National Institute for Health and Care Excellence

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).

1. 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
  • who have imatinib intolerance
  • 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 imatinib1 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.

1The summary of product characteristics (SPC) for imatinib states that the dose may be increased from 400mg to 600mg or 800 mg in patients with chronic phase disease, or from 600mg 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 600mg or 800mg in the chronic phase disease or 800mg in the accelerated phase or blast crisis.

The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://guidance.nice.org.uk/TA241

This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.

© Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: nice@nice.org.uk

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.
Issue Date: January 2012

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