News

Tasigna® secures EU approval

Amy Schofield 21 November 2017

The European Commission has approved Novartis' 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 (TKI) currently approved in the European Union for the treatment of Ph+ CML-CP in children.

The approval follows a positive opinion issued by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use on September 14, 2017, and applies to all EU member states.

This expanded indication is 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.

A total of 69 paediatric patients received nilotinib. These patients were aged two to 18 years and diagnosed with either newly diagnosed Ph+ CML-CP or Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib.

In the newly diagnosed CML patients, the major molecular response (MMR; BCR ABL/ABL <=0.1% International Scale [IS]) rate was 60.0% (95% confidence interval [CI]: 38.7, 78.9) at 12 cycles, with 15 patients achieving MMR. In patients with resistance or intolerance to prior therapy including imatinib, the MMR rate was 40.9% (95% CI: 26.3, 56.8) at 12 cycles, with 18 patients being in MMR. In newly diagnosed CML patients, the cumulative MMR rate was 64.0% by cycle 12. In patients with resistance or intolerance to prior therapy including imatinib, the cumulative MMR rate was 47.7% by cycle 12.

In June, Novartis achieved an important milestone for the Ph+ CML community when Tasigna became the first and only TKI to include information on stopping therapy in adult patients with Ph+ CML-CP in both the first-line setting and after switching from imatinib in the EU label and several other labels throughout the world.

Bruno Strigini, CEO, Novartis Oncology, said: "Treatment options for children with CML have historically been limited, and with this new indication an unmet need has been addressed."

 

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