BRIEF—Tasigna approved for pediatric CML in Europe

Basel’s Novartis has been granted EU approval for its tyrosine kinase inhibitor Tasigna (nilotinib) for certain pediatric chronic myeloid leukemia (CML) patients.

Tasigna is the only second-generation tyrosine kinase inhibitor approved in this indication in Europe.

Novartis Oncology chief executive Bruno Strigini said: "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."

Worldwide, CML is responsible for approximately 10% to 15% of all adult cases of leukemia, with an incidence of one to two cases per 100,000 people per year.

Tasigna is approved in more than 122 countries for indications in this therapeutic area.