Regulatory Affairs

Novartis gets EC approval for Tasigna to treat Ph+ CML-CP in children

PBR Staff Writer Published 21 November 2017

Novartis has secured approval from the European Commission (EC) for its Tasigna (nilotinib) to treat pediatric patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).

Tasigna has also been approved for the treatment of pediatric patients with Ph+ CML-CP with resistance or intolerance to prior therapy including imatinib.

Tasigna said to be the only second-generation tyrosine kinase inhibitor (TKI) currently approved in the European Union (EU) to treat Ph+ CML-CP in children.

The approval was based on two prospective studies of nilotinib in children with Ph+ CML-CP, which were part of a formal pediatric investigation plan agreed upon with the EMA.

CML is a type of cancer in which the body generates cancerous white blood cells. Patients with CML have an abnormality called Philadelphia chromosome, which produces a protein known as BCR-ABL.

In around 122 countries, Tasigna secured approval to treat chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to at least one prior therapy, including Glivec® (imatinib).

In more than 110 countries, Tasigna was approved for the treatment of adult patients with newly diagnosed Ph+ CML in chronic phase.

Novartis Oncology CEO Bruno Strigini said: "Treatment options for children with CML have historically been limited, and with this new indication an unmet need has been addressed.

"Data from two prospective studies demonstrated Tasigna is safe and effective in patients as young as two years old, which is consistent with the established safety profile of Tasigna in adults."