The European Commission has approved Switzerland-based Novartis' Tasigna intended to treat paediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemic in the chronic phase (Ph+ CML-CP), it was reported yesterday.
The product has also been approved for the treatment of paediatric patients with Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib. It is said to be the only second-generation tyrosine kinase inhibitor presently approved in the European Union.
The approval was based on two prospective studies of nilotinib in children with Ph+ CML-CP, which were part of a formal paediatric investigation plan agreed upon with the EMA.
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