The European Commission (EC) has approved Novartis’s Tasigna for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia.
The particular type this is for, is the leukemia in the chronic phase and pediatric patients with Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib.
Tasigna is the only second-generation tyrosine kinase inhibitor (TKI) currently approved in the European Union (EU) for the treatment of Ph+ CML-CP in children. The approval follows a positive opinion issued by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on September 14, 2017 and applies to all EU member states.
Bruno Strigini, CEO, Novartis Oncology, said that the data from two prospective studies demonstrated Tasigna is safe and effective in patients as young as two years old, which is consistent with the established safety profile of Tasigna in adults.