Novartis announced today that the US Food and Drug Administration (FDA) expanded the indication for Tasigna® (nilotinib) to include treatment of first- and second-line pediatric patients one year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Tasigna® (nilotinib) approved for pediatric patients with newly diagnosed Ph+ CML-CP and children with Ph+ CML-CP resistant or intolerant to prior TKI therapy New indication approved under FDA Priority Review designation; provides clinicians with pediatric-specific safety and clinical data Novartis continues commitment to people living with CML, including pediatric patients with this cancer
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