Novartis' Tasigna gets treatment-free remission FDA label expansion

FDA updated the label of Tasigna nilotinib from Novartis AG (NYSE:NVS; SIX:NOVN) to reflect that some chronic myelogenous leukemia (CML) patients could be eligible to stop treatment after achieving a sustained response.

The BCR-ABL tyrosine kinase inhibitor’s label now includes data on treatment-free remission from the open-label Phase II ENESTfreedom and ENESTop trials to treat Philadelphia chromosome-positive (Ph+) CML in chronic phase. At 96 weeks after stopping treatment, Tasigna led to treatment-free remission rates of 48.9% in ENESTfreedom and 53.2% in ENESTop. Novartis defined treatment-free remission as a patient’s ability to maintain a sustained molecular response after stopping tyrosine kinase inhibitor therapy...