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Europe Approves Ponatinib as Orphan Drug for Leukemias -
Zosia Chustecka
Jul 02, 2013
The European Commission has granted marketing authorization to ponatinib (Iclusig, Ariad Pharmaceuticals) as an orphan drug for use in certain leukemia patients who have stopped responding to or cannot tolerate other therapies.
Specifically, ponatinib is indicated for use in adults with chronic myeloid leukemia (CML) in the chronic, accelerated, or blast phase who are resistant to dasatinib (Sprycel) or nilotinib (Tasigna), who are intolerant of dasatinib or nilotinib and for whom subsequent treatment with imatinib (Gleevec) is not clinically appropriate, or who have the T315I mutation.
In addition, it is indicated for adults with Philadelphia (Ph) chromosome-positive acute lymphoblastic leukemia (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.