Medication Monitor

Generic Name (Trade Name—Company)
March 27, 2018


New indication to treat children aged 1 year and older with rare form of leukemia

Novartis announced FDA approval of nilotinib to include treatment of first- and second-line pediatric patients aged 1 year or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).

Nilotinib is also indicated for the treatment of pediatric patients aged 1 year of age or older with Ph+ CML-CP that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy, as well as adult patients with Ph+ CML in chronic phase and accelerated phase that is resistant or intolerant to prior therapy that included imatinib.

Adverse reactions observed in these pediatric studies were generally consistent with those observed in adults, except for laboratory abnormalities of hyperbilirubinemia and transaminase elevation, which were reported at a higher frequency than in adult patients. One patients with resistant or intolerant pediatric CML progressed to advance phase/blast crisis after about 10 months on treatment.