What is the role of nilotinib in the treatment of chronic myelogenous leukemia (CML)?

Updated: May 23, 2021
  • Author: Emmanuel C Besa, MD; Chief Editor: Sara J Grethlein, MD, FACP  more...
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Nilotinib has been found superior to imatinib in patients with newly diagnosed chronic-phase Ph+ CML. [47] In addition, Kantarjian et al reported that nilotinib maintained better efficacy during a minimum follow-up of 24 months. Compared with imatinib, significantly more patients receiving nilotinib achieved a major molecular response, or a complete molecular response at any time, and fewer progressed to accelerated or blast phase. These authors concluded that these results support the use of nilotinib as a first-line treatment option. [48]

In March 2018, FDA approved nilotinib for first- and second-line treatment of pediatric patients aged 1 year and older with Ph+ CML-CP. Approval was based on a cohort of 69 pediatric patients with Ph+ CML-CP enrolled across 2 trials. Patients were either newly diagnosed or resistant/intolerant to prior treatment with a tyrosine kinase inhibitor.

The major molecular response (MMR) in newly diagnosed patients was 60% at 12 cycles, with 15 patients achieving MMR. The cumulative MMR in this group was 64% by cycle 12, and the median time to first MMR was 5.6 months. In the resistant/intolerant group, the MMR rate was 40.9% at 12 cycles, with 18 patients being in MMR. The cumulative MMR rate in this group was 47.7% by cycle 12, and the median time to first MMR was 2.8 months. [49]

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