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FDA Approves Nilotinib for Pediatric Patients With Newly Diagnosed or Resistant/Intolerant Ph+ CML in Chronic Phase

The Food and Drug Administration approved nilotinib (TASIGNA, Novartis Pharmaceuticals Corporation) for pediatric patients one year of age or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.