Novartis said US Food and Drug Administration (FDA) expanded the indication for Tasigna 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).
In the United States, Tasigna is now indicated for the treatment of adult and pediatric patients one year of age or older with newly diagnosed Ph+ CML-CP.
Tasigna is also 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. Worldwide, CML accounts for approximately 3% of newly diagnosed childhood leukemia.
“Novartis’ commitment to people living with CML is reinforced by today’s FDA approval of Tasigna in children,” said Liz Barrett, CEO, Novartis Oncology. “This expanded use, along with the other recent global regulatory Tasigna milestones, underscores our dedication to reimagining medicine and addressing the needs for people with CML, including children with this cancer.”