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Published on 4 July 2013

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ARIAD’s Iclusig® granted marketing authorisation

ARIAD’s Iclusig® (ponatinib) has been granted marketing authorisation by the European Commission as an orphan medicinal product for two indications:
  • The treatment of adult patients 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, and
  • The treatment of adult patients with Philadelphia-chro

    ARIAD’s Iclusig® (ponatinib) has been granted marketing authorisation by the European Commission as an orphan medicinal product for two indications:
    • The treatment of adult patients 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, and
    • The treatment of adult patients with 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.
    “Iclusig’s approval in Europe will offer CML patients, some of whom have run out of other treatment options, a new opportunity to improve their clinical outcome,” said Stephen G. O’Brien, MD PhD, Professor of Haematology at the Northern Institute for Cancer Research at Newcastle University, UK.
    ARIAD was granted accelerated assessment by the Committee for Medicinal Products for Human Use for the Iclusig marketing authorisation application. The aim of accelerated assessment is to expedite the review process for new medicines that address a major public-health interest.


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