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Novartis’ Tasigna Approved to Treat Children With Leukemia

March 26, 2018

The FDA granted approval to Novartis’ Tasigna (nilotinib) for treating pediatric patients with a rare type of leukemia.

The drug’s label was expanded to include patients aged one year or older that have been newly diagnosed with Philadelphia chromosome-positive chronic myeloid (Ph+ CML-CP) in the chronic phase.

Tasigna is also indicated for treatment of pediatric patients the same age with Ph+CML-CP that is resistant or intolerant to prior tyrosine kinase inhibitor therapy. The drug is already approved to treat adults in both situations.

The approvals were based on two studies that evaluated Tasigna’s efficacy and safety in pediatric patients.

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