The US Food and Drug Administration is allowing use of Novartis’ Tasigna to treat paediatric patients with a rare form of leukaemia.
The drug’s label has been expended to include patients aged one year or older newly diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Tasigna (nilotinib) is also indicated for the treatment of pediatric patients of the same age with Ph+ CML-CP resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy.
The new indications are based on two studies evaluating the efficacy and safety the drug in pediatric patients.
In newly diagnosed paediatric patients, the major molecular response rate was found to be 60.0 percent at 12 cycles, while in those with resistance or intolerance to prior TKI therapy, the MMR rate was 40.9 percent.
The therapy is already approved to treat adults in both settings.