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European Commission approves Novartis’s leukemia drug

European Commission (EC) has approved the inclusion of Treatment-free Remission (TFR) data in the Novartis’s Tasigna (nilotinib) Summary of Product Characteristics (SmPC).

TFR is the ability to maintain molecular response (MR) after stopping tyrosine kinase inhibitor (TKI) therapy in Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) patients in chronic phase (CP). This is an important milestone for the Ph+ CML community because Tasigna is now the first and only TKI to include information on TFR in the European Union (EU) label, the company said.

“For more than 15 years, Novartis has been committed to improving upon the standard of care in Ph+ CML,” said Bruno Strigini, CEO, Novartis Oncology. “With this EU approval, we are pleased that results of two studies from our large international Ph+ CML clinical trial program assessing Tasigna discontinuation, ENESTfreedom and ENESTop, now provide physicians with important clinical information for discontinuing therapy in certain patients.”  

The company said that approval by the EC was based on efficacy and safety findings from the 48-week analyses of two open label trials, ENESTfreedom and ENESTop, which showed that more than 50% of Ph+ CML-CP patients who met the rigorous predefined response criteria of the trials were able to maintain TFR after stopping Tasigna in both in the first-line setting and after switching from Glivec (imatinib). No new major safety findings were observed in these studies at the 48-week analyses in patients treated with Tasigna beyond those in the known safety profile of Tasigna.

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