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Europe's Rx Risk Assessment Group Recommends Keeping Iclusig Indications Unchanged

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Originally published Oct. 14.

NEW YORK (GenomeWeb) – The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) completed a review of Ariad Pharmaceuticals' Iclusig (ponatinib) and recommended that the company continue to sell the drug for the leukemia indications for which it is already approved.

In July 2013, Iclusig was approved by European regulators as a treatment for chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia patients who can't receive other tyrosine kinase inhibitors (TKIs), such as Sprycel (dasatinib) or Gleevec (imatinib), or who have the T315I mutation. PRAC, an EMA committee that monitors drug safety issues, reviewed data on Iclusig after studies showed it was causing life threatening blood clots and narrowing of blood vessels in some patients.

"The PRAC recommendation provides insightful guidance to healthcare professionals and patients regarding the use of Iclusig in patients with Ph-positive leukemias and importantly, leaves the original Iclusig indication statement unchanged," Ariad CEO Harvey Berger said in a statement. PRAC's recommendations will be considered next by the Committee for Medicinal Products for Human Use later this month, and then by the European Commission by year end.

In contrast, after health regulators in the US reviewed the safety data on Iclusig, the US Food and Drug Administration decided to allow Ariad to market the drug but with a narrower indication.

The FDA initially approved Iclusig in December of 2012 as a treatment for advanced chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblasic leukemia patients who are resistant or intolerant to prior treatment with other tyrosine kinase inhibitors. Ariad temporarily stopped selling Iclusig in the US late last year after studies raised safety concerns. After reviewing the data, the FDA altered Iclusig's indication so that it could be given only to T315I-positive, advanced CML, or Ph-positive ALL patients. Additionally, Ariad can also market the drug for advanced CML or Ph-positive ALL patients "for whom no other TKI is indicated," the FDA approved label states.

However, back in the EU, in keeping Iclusig's original indications intact, PRAC did recommend that healthcare providers monitor patients' responses to Iclusig according to clinical guidelines; consider lowering the drug dose after they've achieved a major cytogenetic response; and discontinue the drug if patients haven't achieved a complete hemtatologic response in three months. The committee also noted that "the risk of vascular occlusive events is likely dose-related," and such risk information will need to be included in drug labeling.

Ariad is planning to soon launch a randomized study for Iclusig to evaluate how lowering the dose of the drug impacts efficacy and safety. Additionally, the company is enrolling subjects in studies involving Iclusig as a non-small cell lung cancer treatment for those with RET translocations; medullary thyroid cancer treatment for those with or without RET mutations; endometrial cancer patients with FGFR2 mutations; FLT3-positive acute myeloid leukemia patients; and Philadelphia-chromosome-positive acute lymphoblastic leukemia patients. The firm plans to also study the drug in other leukemia indications and in bile duct carcinoma patients with FGFR fusions.

Despite the regulatory hurdles for Iclusig, Ariad reported that in the second quarter of this year the drug brought in nearly $8 million in the US and $4 million in Europe. This is in comparison to the first quarter, when the drug sold $4.7 million in the US and $3.3 million in Europe. In the second quarter, the company didn't record in its revenues more than $2 million in Iclusig sales to France where pricing and reimbursement negotiations are ongoing and are slated for completion in the first half of next year.

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