Novartis’ Tasgina receives new paediatric leukaemia approval in Europe

Novartis has announced that its cancer drug Tasigna has been approved in Europe for the treatment of certain forms of leukaemia in children.

The European Commission has approved Tasigna for the treatment of paediatric patients with newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia in the chronic phase (Ph+ CML-CP), and those with Ph+ CML-CP with resistance or intolerance to prior therapy.

Tasigna is the only second-generation tyrosine kinase inhibitor currently approved in the EU for the treatment of Ph+ CML-CP in children, with the latest approval based on two prospective studies of the drug.

In these trials, it was shown that Tasigna was able to generate strong major molecular responses, as well as demonstrating a positive safety profile in terms of adverse reactions.

Bruno Strigini, chief executive officer for Novartis Oncology, 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.”

Tasigna was first approved in the EU in 2007 and earlier this year, Tasigna received European Commission (EC) approval for inclusion of Treatment-free Remission data in the EU product label. With this EC approval, Tasigna became the first and only TKI to include information on stopping therapy in adult patients with Ph+ CML-CP in both the first-line setting and after switching from imatinib in the EU label.

With over 20 years of experience within the pharmaceutical market, we at Zenopa have the knowledge, skills and expertise to help find the right job for you. To find out more about the current pharmaceutical roles we have available, you can search for the latest job roles, register your details, or contact the team today.