Healthcare company Novartis reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for the expanded use of Tasigna in 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).

With this new US FDA's approval, Tasigna (nilotinib) is now indicated for the treatment of adult and pediatric patients one year of age or older with newly diagnosed Ph+ CML-CP, added the company.

According to the company, Tasigna is indicated for the treatment of pediatric patients one year of age or older with Ph+ CML-CP resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy, as well as adult patients with Ph+ CML in chronic phase and accelerated phase, resistant or intolerant to prior therapy that included imatinib. This approval is the latest in a series of regulatory milestones that broadens the understanding and clinical use of Tasigna.

CML is a type of blood cancer where the body produces malignant white blood cells. Almost all patients with CML have an abnormality known as the "Philadelphia chromosome," which produces a protein called BCR-ABL. This protein aids the proliferation of malignant white blood cells in affected patients.

The new indications under the US FDA's Priority Review designation are based on the company's two studies evaluating the efficacy and safety of nilotinib in pediatric patients with Ph+ CML-CP. A total of 69 Ph+ CML-CP pediatric patients received nilotinib. The major molecular response International Scale [IS]) rate was 60.0% at 12 cycles, providing clinicians with pediatric-specific safety and clinical data.