Novartis' Tasigna gets EU label update to include treatment-free remission data

Novartis AG (NYSE:NVS; SIX:NOVN) said the European Commission approved a label expansion for Tasigna nilotinib to include data on treatment-free remission from the Phase II ENESTfreedom and ENESTop trials to treat Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in chronic phase. Novartis said the endpoint is a patient’s ability to maintain molecular response after stopping tyrosine kinase inhibitor therapy.

Tasigna led to treatment-free remission at 48 weeks after stopping treatment in 51.6% and 57.9% of patients in ENESTfreedom and ENESTop, respectively...