Novartis drug Tasigna receives EU approval for inclusion of TFR data in product label

Novartis announced that the European Commission (EC) has approved the inclusion of Treatment-free Remission (TFR) data in the 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.

“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 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.

An important part of the ENESTfreedom and ENESTop trials was regular and frequent molecular monitoring of BCR-ABL levels with a well-validated assay able to measure BCR-ABL transcript levels down to MR4.5 (BCR-ABL1 International Scale [IS] <= 0.0032%). Frequent patient monitoring after discontinuation of Tasigna allows timely determination of loss of MR4.0 (BCR-ABL1 IS <= 0.01%) and major molecular response (MMR; BCR-ABL1 IS <= 0.1%) and need for treatment re-initiation.