ICLUSIG (ponatinib), tyrosine kinase inhibitor

Moderate improvement in the treatment of all phases of chronic myeloid leukaemia (CML) or Ph+ ALL in the presence of the T315I mutation.

Minor improvement in the treatment of Ph+ acute lymphoblastic leukaemia (ALL) in the absence of mutation T315I, in case of resistance or intolerance to dasatinib and when subsequent treatment with imatinib is not clinically appropriate.

No demonstrated improvement in the treatment of all phases of CML in the absence of the T315I mutation, in patients previously treated with one or more tyrosine kinase inhibitors and for whom imatinib, nilotinib and dasatinib are not regarded as appropriate treatments.

• ICLUSIG has Marketing Authorisation in adults with:

- chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation

- Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation

• Its efficacy was demonstrated in a non-comparative study with, as primary efficacy endpoints, the major cytogenetic response and the major haematological response.

• ICLUSIG is:

- a first-line treatment for CML and Ph+ ALL with the T315I mutation

- a next-line treatment for CML and Ph+ ALL patients without the T315I mutation.

- an alternative to bosutinib (BOSULIF) in the next-line treatment of all phases of CML in the absence of the T315I mutation.