Ariad Pharmaceuticals Inc. (ARIA) and Israel's Medison Pharma Ltd, said that the Israeli Ministry of Health has granted regulatory approval for Iclusig, or ponatinib, in Israel.
The approval in Israel is for adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia or 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.
The drug has also been approved in Israel for adult patients with 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.
Ariad Pharma submitted its application for Iclusig to the Israeli Ministry of Health in June 2014. The company expects commercial launch of Iclusig to occur in the second quarter of 2015.
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