ADVERTISEMENT
FDA Grants Expanded Approval of Treatment for Pediatric Patients With CML
The US Food and Drug Administration (FDA) has granted approval for a drug to include treatment of first- and second-line pediatric patients with chronic myeloid leukemia (CML).
Nilotinib (Tasigna, Novartis) is now approved to be used in first- and second-line treatment of patients 1 year of age or older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
Nilotinib was already indicated for the treatment of adult patients with newly diagnosed Ph+ CML-CP, the treatment of pediatric patients 1 year of age or older with Ph+ CML-CP resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy, and adult patients with Ph+ CML in chronic phase and accelerated phase, resistant or intolerant to prior therapy that included imatinib.
"Novartis' commitment to people living with CML is reinforced by today's FDA approval of Tasigna in children," said Liz Barrett, CEO, Novartis Oncology, in a press release (March 22, 2018). "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."—Janelle Bradley
