The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Iclusig 15 mg and 45 mg film-coated tablets intended for the treatment of chronic myeloid leukaemia ( CML ) and Philadelphia chromosome positive acute lymphoblastic leukaemia ( Ph+ ALL ).
Iclusig was designated as an orphan medicinal product on 2 February 2010.
The active substance of Iclusig is Ponatinib, a protein kinase inhibitor. It acts by inhibiting the BCR-ABL kinase.
The benefits with Iclusig are its cytogenetic and haematological response rates in patients with CML and Ph+ ALL including patients bearing T315I mutation.
The most common side effects are platelet count decreased, rash, dry skin, and abdominal pain.
The approved indication is: Iclusig is indicated in adult patients with
a) chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia 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;
b) Philadelphia chromosome positive acute lymphoblastic leukaemia 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. ( Xagena )
Source: European Medicines Agency, 2013