Novartis announced that the Food and Drug Administration (FDA) has approved Tasigna (nilotinib) for use in first- and second-line pediatric patients aged ≥1 year with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).

The expanded approval was supported by 2 studies evaluating the safety and efficacy of Tasigna in 69 pediatric patients aged 2 to <18 years with Ph+ CML-CP who were either newly diagnosed (first-line) or who were resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy (second-line). Among first-line pediatric patients, the major molecular response (MMR) rate was 60.0% (95% CI: 38.7, 78.9) at 12 cycles with 15 patients achieving MMR (defined as BCR ABL/ABL ≤0.1% International Scale [IS]). The cumulative MMR rate was 64.0% by 12 cycles; median time to first MMR was 5.6 months. 

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Among second-line pediatric patients, the MMR rate was 40.9% (95% CI: 26.3, 56.8) at 12 cycles with 18 patients achieving MMR. The cumulative MMR rate was 47.7% by 12 cycle; median time to first MMR was 2.8 months.

Tasigna, a kinase inhibitor, is already indicated to treat adults with newly diagnosed Ph+ CML-CP, and chronic and accelerated phase Ph +CML in adults resistant or intolerant to imatinib. It is available as 150mg and 200mg strength capsules.

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