Tasigna Gains Expanded Indication for Rare Pediatric Leukemia

Adverse reactions observed in pediatric studies were generally consistent with those observed in adults
Adverse reactions observed in pediatric studies were generally consistent with those observed in adults

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.

For more information call (800) 693-9993 or visit Tasigna.com.