Posted by Michael Wonder on 20 Nov 2017
Novartis drug Tasigna (nilotinib) secures EU approval for first and second-line treatment of Ph+ CML-CP in children
20 November 2017 - Tasigna is the first and only second-generation tyrosine kinase inhibitor approved in the EU for the treatment of Ph+ CML-CP in children.
Novartis announced today that the European Commission approved Tasigna (nilotinib) for the treatment of paediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia in the chronic phase (Ph+ CML-CP) and paediatric patients with Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib. Tasigna is the only second-generation tyrosine kinase inhibitor currently approved in the European Union for the treatment of Ph+ CML-CP in children.
The approval follows a positive opinion issued by the EMA's CHMP on 14 September 2017 and applies to all EU member states.
