Novartis Oncology China Announces NMPA Approval of Tasigna® (Nilotinib) for Pediatric Chronic Myeloid Leukemia

Recently, Tasigna® (nilotinib), a product under Novartis Oncology (China), received approval from the National Medical Products Administration for a new indication: the treatment of chronic myeloid leukemia in children aged 2 years and older.

This marks another indication approved in China, following the 2009 approval of Tasigna® (nilotinib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic or accelerated phase who are resistant or intolerant to prior therapy (including imatinib), and the 2016 approval for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

It is reported that the approval of the new indication makes Tasigna® (nilotinib) the only second-generation tyrosine kinase inhibitor (TKI) approved in China for the treatment of pediatric chronic myeloid leukemia.

Source: Novartis