Molecular monitoring and target milestones¹

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) 2026

a, BCR::ABL1 IS ≤0.1% at 12 months is associated with a very low probability of subsequent loss of response and a high likelihood of achieving a subsequent deep molecular response (DMR MR4.0; BCR::ABL1 IS ≤0.01%), which is a prerequisite for a trial of treatment-free remission (TFR).

b, Achievement of response milestones must be interpreted within the clinical context. Patients with BCR::ABL1 only slightly >10% at 3 months and/or with a steep decline from baseline may achieve <10% at 6 months and have generally favorable outcomes. Therefore, it is important to interpret the value at 3 months in this context before making drastic changes to the treatment strategy. Same dose of TKI can be continued for another 3 months but imatinib is associated with slower molecular responses.

c, Achievement of response milestones must be interpreted within the clinical context. Patients achieving MCyR (BCR::ABL1 IS ≤10%) at 12 months have good long-term survival. Patients with more than 50% reduction compared to baseline or minimally above the 10% cutoff can continue the same dose of TKI for another 3 months. Consider switching to alternate 2G TKI or 3G TKI or allosteric TKI in the absence of continuing decline in BCR::ABL1 transcript levels.
d, Switching to an alternate TKI for intolerance is appropriate for patients with disease responding to TKI therapy. See Special Considerations for the use of TKI Therapy (CML-C).
e, TKIs are available in different formulations, dosage forms, and strengths that are subject to different administration instructions. These products are not interchangeable. Refer to package insert for full prescribing information for specific TKIs: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm.
f, FDA-approved generic drugs are appropriate substitutes for brand name drugs (Kantarjian H, et al. Lancet Haematol 2022;9:e854-e861; Haddad FG, Kantarjian H. J Natl Compr Canc Netw 2024;22:e237116). Brand name and generic drugs approved by the regulatory authorities based on pharmacokinetic equivalence can be used interchangeably. Clinicians should be aware of the potential pharmacokinetic variability and monitor patients closely during transitions, particularly for drugs with narrow therapeutic windows such as nilotinib and bosutinib.

g, Consider referral to a specialized CML center and/or enrollment in a clinical trial.

h, Consider myeloid mutation panel to identify BCR::ABL1–independent resistance mutations in patients with no BCR::ABL1 kinase domain mutations.

i, Discontinuation of TKI with careful monitoring is feasible in selected patients. See Discontinuation of TKI Therapy (CML-H).

j, Switching from imatinib to a 2G TKI or allosteric TKI may improve response. The side effect profile of alternative TKIs may differ.

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