On October 10, 2014 ARIAD Pharmaceuticals reported 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 (Press release Ariad, OCT 10, 2014, View Source;p=RssLanding&cat=news&id=1976197 [SID:1234500818]).

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"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, (3) consideration of Iclusig discontinuation if a complete haematologic response has not been achieved by three months. Further information is provided indicating that the risk of vascular occlusive events is likely dose-related. An update of the Warning and Precautions and Undesirable Effects sections is also provided for inclusion in the Iclusig SmPC.

"The recommendation from the PRAC confirms a positive benefit-risk assessment for Iclusig after thorough consideration of updated safety information," said Stephen G. O’Brien, M.D., Ph.D., Professor of Haematology at the Northern Institute for Cancer Research at Newcastle University, United Kingdom. "This is a good outcome for patients and healthcare professionals in Europe as it continues to offer a treatment option to CML patients who have become resistant to, or intolerant of, certain other TKIs."

The PRAC is the committee at the EMA that is responsible for assessing and monitoring safety issues for human medicines. The PRAC’s recommendations are considered by the CHMP when it adopts opinions for centrally authorized medicines and referral procedures.