Posted by Michael Wonder on 06 Jun 2017
Novartis drug Tasigna receives EU approval for inclusion of treatment-free remission data in product label
6 June 2017 - Approval based on Novartis trials evaluating treatment-free remission with Tasigna in Ph+ CML-CP patients in both the first-line setting and after switching from Glivec.
Novartis announced today that the European Commission has approved the inclusion of Treatment-free Remission (TFR) data in the Tasigna (nilotinib) Summary of Product Characteristics.
TFR is the ability to maintain molecular response after stopping tyrosine kinase inhibitor (TKI) therapy in Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) patients in chronic phase. 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 label.
