ARIAD and STA Announce Approval of Iclusig (Ponatinib) in Australia
Sentiment: Strong Buy
ARIAD Pharmaceuticals, Inc. (ARIA) today announced that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded its review of Iclusig® (ponatinib) under the Article 20 referral procedure and has recommended that Iclusig continue to be used in Europe in accordance with its already approved indications.
“We are grateful for the rigorous and in-depth review provided by the PRAC and the Scientific Advisory Group for Oncology,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “The PRAC recommendation provides insightful guidance to healthcare professionals and patients regarding the use of Iclusig in patients with Ph+ leukemias and importantly, leaves the original Iclusig indication statement unchanged. We look forward to consideration and adoption of these recommendations by the CHMP later this month and authorization by the European Commission by the end of the year.”
The authorized indications of Iclusig in Europe, as approved in July 2013, are as follows:
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, or
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.
Other recommendations made by the PRAC related to the Iclusig Summary of Medicinal Product Characteristics (SmPC) include, (1) patient monitoring for response according to standard clinical guidelines, (2) consideration of Iclusig dose-reduction following achievement of major cytogenetic response with subsequent monitoring of response and,
Sentiment: Strong Buy