Novartis: leukemia drug gets European approval.
(CercleFinance.com) - The European Commission has approved Novartis' Tasigna for first- and second-line treatment of children with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP), the Swiss firm said on Monday.
The EC also approved Tasigna for the treatment of pediatric patients with Ph+ CML-CP with resistance or intolerance to prior therapy, including imatinib.
The approval - which follows a positive opinion issued by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in September - and applies to all EU member states.
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