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The Food and Drug Administration (FDA) has approved updated labeling for Tasigna (nilotinib; Novartis) making it the first BCR-ABL tyrosine kinase inhibitor (TKI) to have treatment-free remission (TFR) data in the prescribing information. TFR refers to the ability to maintain a sustained molecular response after discontinuing TKI therapy in patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP).
The approved criteria to attempt and monitor TFR was based on safety and efficacy data from 96-week analyses of two Phase 2 open-label trials: ENESTfreedom (n=215) and ENESTop (n=8). The studies assessed the potential to maintain major moleculat response (MMR) (BCR-ABL1 ≤0.1%) after stopping Tasigna among eligible patients with Ph+ CML-CP.
In ENESTfreedom, 48.9% of CML patients were able to discontinue therapy and remain in MMR at 96 weeks. Of those who restarted Tasigna due to MMR loss, 98.9% were able to regain MMR. In ENESTop, 53.2% of patients were able to remain in TFR at 96 weeks. Of those who restarted Tasigna due to confirmed loss of MR4.0 or loss of MMR, 92.9% regained both MR4.0 (BCR-ABL/ABL≤0.01% IS) and MR4.5 (BCR-ABL≤0.0032% IS).
Regarding safety, the data were consistent with previously published studies and the known safety profile of Tasigna. The labeling states that discontinuation of Tasigna should only be attempted under close supervision of a physician. Moreover, patient monitoring should be frequent with an FDA-approved test after treatment discontinuation so that detection of MMR loss and MR 4.0 can be promptly identified and managed.
“Patients diagnosed with CML generally face a lifetime of treatment to keep their leukemia from growing or recurring,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval shows that some patients may be able to stop treatment with Tasigna altogether if they are showing a strong response to therapy. While we welcome this progress in patient care, it’s important to note that any discontinuation of treatment still means patients must be regularly monitored for disease recurrence.”
Tasigna is currently approved for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to prior therapy that included imatinib (Gleevec) and for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
For more information call (888) 669-6682 or visit Tasigna.com.
