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FDA updates Tasigna label to include information on discontinuation

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The FDA updated the label for nilotinib to include guidance on treatment discontinuation, monitoring criteria following discontinuation and treatment reinitiation for patients with Philadelphia chromosome-positive chronic myeloid leukemia who achieved a sustained molecular response.

Patients with Ph+CML in the chronic phase may be considered for treatment discontinuation after at least 3 years of nilotinib (Tasigna, Novartis) treatment if they are newly diagnosed or have achieved a sustained molecular response (MR4.5) if they have resistant or intolerant disease. Typical BCR-ABL transcripts also must be present.

An FDA-authorized test with a detection limited below at least MR4.5 must be used to determine patients’ eligibility for discontinuation, and to monitor patients to detect loss of remission following discontinuation.

The FDA based these recommendations on data from the ENESTfreedom and ENESTop single-arm trials, which evaluated treatment-free remission among patients with Ph+CML in chronic phase.

As HemOnc Today previously reported, 51.6% of the 190 newly diagnosed patients enrolled on ENESTfreedom who discontinued nilotinib after at least 3 years remained in treatment-free remission for 48 weeks, and 48.9% remained in treatment-free remission after 96 weeks. Of patients who restarted treatment due to loss of molecular response, 98.9% regained major molecular response and 92% regained MR4.5 by the 96-week data cutoff date.

In ENESTop, 126 patients discontinued nilotinib after 3 or more years following treatment with imatinib. Overall, treatment-free remission occurred among 57.9% after 48 weeks and 53.2% after 96 weeks. Almost all patients (92.9%) regained molecular response (MR4 or MR4.5) following treatment reinitiation.

No patients in either trial progressed to accelerated or blast phases of CML during treatment-free remission.

Common adverse events among patients who discontinued nilotinib included musculoskeletal symptoms — some of which were prolonged — such as body aches, bone pain and extremity pain.

The FDA noted long-term outcomes of patients discontinuing vs. continuing treatment are unknown.