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Iclusig?s original indication will remain unchanged after a thorough examination of its safety information by EMA.
Ariad Pharmaceuticals announced Oct. 10, 2014 that the Pharmacovigiliance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has finished reviewing Iclusig (ponatinib) and has concluded that the drug be used in Europe in accordance with its previously approved indications. In the US last year, FDA asked Ariad to suspend marketing and sales of Iclusig because of the risk of life-threatening blood clots and severe narrowing of blood vessels.
Iclusig (ponatinib) is used to treat adults with a specific type of abnormal gene mutation (T315I-positive), chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukemia (CML), or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). It is also indicated for adults with chronic-phase, accelerated-phase, or blast-phase CML or Ph+ ALL who cannot receive any other tyrosine kinase inhibitor (TKI) medicines.
Ariad reported in a press release that the recommendations made by PRAC to the Iclusig Summary of Medicinal Product Characteristics include: patient monitoring for response according to standard clinical guidelines; consideration of Iclusig dose reduction following achievement of major cytogenetic response with subsequent monitoring of response; and consideration of Iclusig discontinuation if a complete hematologic response has not been achieved by three months. PRAC also included an update of the Warnings and Precautions and Undesirable Effects section in the summary as well as further information about the risk of vascular occlusive events.
“The recommendation from the PRAC committee confirms a positive benefit-risk assessment for Iclusig after thorough consideration of updated safety information,” said Stephen G. O’Brien, MD, PhD, professor of hematology at the Northern Institute for Cancer Research at Newcastle University in the United Kingdom, in a press release. “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.”