Nilotinib update acknowledges discontinuation feasibility
medwireNews: The US FDA has updated labeling for the tyrosine kinase inhibitor nilotinib to reflect the possibility of treatment discontinuation for chronic myeloid leukemia (CML) patients who achieve a durable response to treatment.
The patients must have sustained a deep molecular response (MR4.5; BCR–ABL1 ≤0.0032%) and used nilotinib for at least 3 years before considered eligible for discontinuation, and patients must continue to be monitored using an FDA-authorized test with a detection limit below at least MR4.5 during treatment-free remission.
The recommendation follows findings from the ENESTfreedom and ENESTop trials of chronic phase CML patients which showed that approximately half of patients maintained remission for around 2 years after stopping treatment.
Moreover, there were no cases of progression to accelerated phase or blast phase CML in the trial participants, and most patients who experienced molecular relapse were able to regain their deep molecular response on beginning treatment again.
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