Novartis receives EU approval for Tasigna label update

Novartis has had a proposed label update for its cancer drug Tasigna approved by the European Commission.

The regulator has ratified the inclusion of treatment-free remission data in Tasigna's summary of product characteristics, making it the first and only tyrosine kinase inhibitor therapy in Europe to include this information.

It shows that patients with chronic Philadelphia chromosome-positive chronic myeloid leukaemia (CML) are able to maintain molecular response even after stopping therapy.

This approval was based on efficacy and safety findings from 48-week analyses of two open-label trials, ENESTfreedom and ENESTop, which showed that more than 50 percent of patients who met predefined response criteria were able to maintain remission after stopping Tasigna treatment both in the first-line setting and after switching from Glivec.

Bruno Strigini, chief executive officer of Novartis Oncology, said: "We are pleased that results of two studies from our large international Ph-positive CML clinical trial programme assessing Tasigna discontinuation, ENESTfreedom and ENESTop, now provide physicians with important clinical information for discontinuing therapy in certain patients."

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