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June 2, 2014
07:39 EDTARIAARIAD announces longer-term follow up from Phase 1, Phase 2 Iclusig trials
ARIAD Pharmaceuticals announced longer-term follow up from its Phase 1 and pivotal Phase 2 trials of Iclusig, its approved BCR-ABL inhibitor, in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. The studies now show that with a median follow-up of 42.5 months for chronic-phase CML patients in the Phase 1 trial, Iclusig continues to demonstrate anti-leukemic activity in those who had limited treatment options, and that deep and durable responses have been maintained in CP-CML patients in the PACE trial with 87 percent estimated to remain in major cytogenetic response at two years. Longer-term safety data show that careful benefit/risk evaluation should guide the decision to use ponatinib therapy, particularly in patients who may be at increased risk for vascular occlusive events.
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October 24, 2014
07:37 EDTARIAARIAD announces CHMP adopts final opinion on Iclusig
ARIAD Pharmaceuticals announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted its final opinion on Iclusig following the recommendations made by the Pharmacovigilance Risk Assessment Committee earlier this month. The PRAC conducted an 11-month review of the available data on Iclusig and consulted with a scientific advisory group in oncology. This week, the EMA recommended that Iclusig continue to be used in accordance with its already approved indications as a treatment of certain leukaemias and confirmed that the benefit-risk profile of Iclusig continues to be positive in each of these indications. The EMA also recommended additional warnings in the European product information to minimize the risk of vascular events. The company said, "We are now well positioned to complete pricing and reimbursement negotiations in Europe and to ensure that Iclusig is available to appropriate Philadelphia-chromosome positive leukaemia patients."

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