Novartis’s Tasigna scores EU approval in paediatric patients
Novartis’s Tasigna (nilotinib) has received European Commission approval for the treatment of newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) and Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib, in paediatric patients, it has emerged.
The EC issued the approval based on data generated via two prospective studies of 69 paediatric patients aged between 2 and 18 years old, each diagnosed with Ph+ CML-CP or Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib. The results demonstrated that Tasigna generated a major molecular response rate of 60%, dropping to 40.9% in those with resistance or intolerance. This rate rose to 64% in newly diagnosed CML patients.
The decision makes Tasigna that only second-generation tyrosine kinase inhibitor (TKI) currently approved in Europe.
“Treatment options for children with CML have historically been limited, and with this new indication an unmet need has been addressed,” commented Bruno Strigini, CEO of Novartis Oncology. “Data from two prospective studies demonstrated Tasigna is safe and effective in patients as young as two years old, which is consistent with the established safety profile of Tasigna in adults.”
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