Announces adoption of final opinion for Iclusig by Committee for Medicinal Products for human use in Europe
- Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted its final opinion on Iclusig(ponatinib) following the recommendations made by the Pharmacovigilance Risk Assessment Committee (PRAC) 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.