Ponatinib for Treating Chronic Myeloid Leukaemia and Acute Lymphoblastic Leukaemia (TA451)

Technology Appraisal Guidance No. 451

Source: National Institute for Health and Care Excellence

1. Guidance

1.1 Ponatinib is recommended, within its marketing authorisation, as an option for treating chronic-, accelerated- or blast-phase chronic myeloid leukaemia in adults when:

  • the disease is resistant to dasatinib or nilotinib or
  • they cannot tolerate dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate or
  • the T315I gene mutation is present.

1.2 Ponatinib is recommended, within its marketing authorisation, as an option for treating Philadelphia-chromosome-positive acute lymphoblastic leukaemia in adults when:

  • the disease is resistant to dasatinib or
  • they cannot tolerate dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate or
  • the T315I gene mutation is present.

1.3 Ponatinib is recommended only if the company provides the drug with the discount agreed in the patient access scheme.


A copy of the full document and background is available on the Internet at 

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: [email protected]

Ponatinib for treating chronic myeloid leukaemia and acute lymphoblastic leukaemia.
Issue Date: June 2017


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