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June 1, 2014
13:07 EDTARIAARIAD presents updated Phase 1/2 data on AP26113
ARIAD Pharmaceuticals announced updated clinical results on its investigational tyrosine kinase inhibitor, TKI, AP26113, in patients with advanced non-small cell lung cancer, NSCLC, from an ongoing Phase 1/2 trial. These study results show anti-tumor activity of AP26113 in patients with crizotinib-resistant anaplastic lymphoma kinase, ALK, positive NSCLC, including patients with brain metastases. Crizotinib is approved for ALK-positive NSCLC patients. The updated Phase 1/2 results are being presented at the 2014 American Society of Clinical Oncology, ASCO, annual meeting in Chicago. “The data from the Phase 2 portion of the trial show that AP26113 exhibits anti-tumor activity in patients with crizotinib-resistant ALK rearranged NSCLC, as well as crizotinib-naïve ALK rearranged NSCLC,” stated Scott N. Gettinger, M.D., associate professor of medicine at Yale School of Medicine. “Importantly, AP26113 demonstrates activity against brain metastases in patients with prior crizotinib therapy, including responses of clinically meaningful duration.”
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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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