Posted by Michael Wonder on 15 Nov 2018
Inclusion of data on treatment discontinuation in the Tasigna product monograph approved by Health Canada for CML patients who achieve a sustained molecular response
13 November 2018 - Approval is based on two studies showing more than half of patients remained in remission after stopping treatment.
Novartis is pleased to announce that Health Canada has approved the inclusion of treatment discontinuation (treatment free remission – TFR) data in the Tasigna (nilotinib) Product Monograph. Tasigna is the first tyrosine kinase inhibitor to include data in the Product Monograph on attempting treatment discontinuation in eligible Philadelphia chromosome positive chronic myeloid leukaemia (Ph+ CML) patients who have achieved a sustained molecular response.
Sustained molecular response achieved by patients over several years on treatment led to studies investigating the ability to maintain response after stopping treatment. The results of two major Novartis studies, ENESTfreedom and ENESTop, formed the basis for the Health Canada approval of the inclusion of the TFR data in the Tasigna Product Monograph.
