Posted by Michael Wonder on 22 Mar 2018
Novartis drug Tasigna approved by FDA to treat children with rare form of leukaemia
22 March 2018 - New indication approved under FDA Priority Review designation; provides clinicians with paediatric-specific safety and clinical data.
Novartis announced today that the US FDA expanded the indication for Tasigna (nilotinib) to include treatment of first- and second-line paediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
In the United States, Tasigna is now indicated for the treatment of adult and paediatric patients one year of age or older with newly diagnosed Ph+ CML-CP. Tasigna is also indicated for the treatment of paediatric patients one year of age or older with Ph+ CML-CP resistant or intolerant to prior tyrosine kinase inhibitor therapy, as well as adult patients with Ph+ CML in chronic phase and accelerated phase, resistant or intolerant to prior therapy that included imatinib.
