FDA updates label of Novartis’ nilotinib to include treatment discontinuation recommendations for CML after sustained response

The Food and Drug Administration (FDA) updates the product label for nilotinib (Tasigna, Novartis) to include dosing recommendations for patients with chronic myeloid leukemia in the chronic phase (CML-CP) who have been taking nilotinib for 3 years or more, and whose leukemia has responded to treatment according to specific criteria as detected by a test that has received FDA marketing authorization, may be eligible to stop taking nilotinib. The information about discontinuing nilotinib is based on 2 single-arm trials of patients with Philadelphia chromosome–positive (Ph+) CML-CP: ENESTfreedom (Evaluating Nilotinib Efficacy and Safety in Clinical Trials – Following REsponsE in De nOvo CML-CP Patients) and ENESTop (Evaluating Nilotinib Efficacy and Safety Trial). An important part of both trials was regular and frequent monitoring of specific genetic (RNA) information that specifies the BCR-ABL protein level in the blood. Nilotinib is now the first and only BCR-ABL tyrosine kinase inhibitor to include in its FDA-approved prescribing information data about attempting treatment discontinuation in eligible adult patients with Ph+ CML-CP after achieving sustained deep molecular response of MR4.5 (BCR-ABL1 International Scale ≤0.0032%).

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