1 Recommendations

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.