TASIGNA (nilotinib), tyrosine kinase inhibitor (ITK)
Reason for request
High clinical benefit in the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in the chronic phase, in the event of resistance or intolerance to imatinib, and minor clinical improvement in the therapeutic strategy.
Insufficient clinical benefit to justify its reimbursement in the treatment of children recently diagnosed with Ph+ CML in the chronic phase.
TASIGNA has MA in the treatment of paediatric patients recently diagnosed with Ph+ CML in the chronic phase and in the event of resistance or intolerance to imatinib.
In children, its short-term efficacy is demonstrated on the cytogenic and molecular responses, without efficacy being demonstrated on mortality.
It provides a response to an unmet medical need in children resistant or intolerant to imatinib, first-line gold standard treatment.
In light of the limited data and the absence of direct comparison to imatinib, its role in recently diagnosed children is not established.
Clinical Added Value