Novartis’ Tasigna gets FDA approval for rare leukaemia in children
Novartis has received approval from the US Food and Drug Administration (FDA) for the use of its Tasigna (nilotinib) drug to treat Philadelphia chromosome-positive chronic myeloid leukaemia in the chronic phase (Ph+ CML-CP) in children.
Ph+CML is caused by the abnormal production of protein from a gene called BCR-ABL1. A signal sent by the BCR-ABL1 protein is responsible for the production of leukemic cells. Tasigna is designed to block this signal to allow the growth of healthy blood cells.
Tasigna has been approved for use in first and second-line paediatric patients aged one year or above.
Previously, the drug was indicated for newly diagnosed Ph+CML-CP in adults and paediatric patients with Ph+CML-CP resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. It is also indicated for adult with Ph-CML in chronic and accelerated phase, or resistant to prior therapy.
Read more: https://www.pharmaceutical-technology.com/news/novartis-tasigna-gets-approval-for-rare-leukaemia-in-us-children/
Ph+CML is caused by the abnormal production of protein from a gene called BCR-ABL1. A signal sent by the BCR-ABL1 protein is responsible for the production of leukemic cells. Tasigna is designed to block this signal to allow the growth of healthy blood cells.
Tasigna has been approved for use in first and second-line paediatric patients aged one year or above.
Previously, the drug was indicated for newly diagnosed Ph+CML-CP in adults and paediatric patients with Ph+CML-CP resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy. It is also indicated for adult with Ph-CML in chronic and accelerated phase, or resistant to prior therapy.
Read more: https://www.pharmaceutical-technology.com/news/novartis-tasigna-gets-approval-for-rare-leukaemia-in-us-children/