Faderl S, Talpaz M, Estrov Z, O’Brien S, Kurzrock R, Kantarjian HM. The biology of chronic myeloid leukemia. N Engl J Med. 1999;341(3):164–72.

Article  CAS  PubMed  Google Scholar 

Jabbour E, Kantarjian H. Chronic myeloid leukemia: 2014 update on diagnosis, monitoring, and management. Am J Hematol. 2014;89(5):547–56.

Article  CAS  PubMed  Google Scholar 

Bonifacio M, Stagno F, Scaffidi L, Krampera M, Di Raimondo F. Management of chronic myeloid leukemia in advanced phase. Front Oncol. 2019;9:1132.

Article  PubMed  PubMed Central  Google Scholar 

Hochhaus A, Baccarani M, Silver RT, Schiffer C, Apperley JF, Cervantes F, et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020;34(4):966–84.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Ono T. Which tyrosine kinase inhibitors should be selected as the first-line treatment for chronic myelogenous leukemia in chronic phase? Cancers. 2021;13(20):5116.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Cortes JE, Saglio G, Kantarjian HM, Baccarani M, Mayer J, Boque C, et al. Final 5-year study results of DASISION: the dasatinib versus imatinib study in treatment-naive chronic myeloid leukemia patients trial. J Clin Oncol. 2016;34(20):2333–40.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Kantarjian HM, Hughes TP, Larson RA, Kim DW, Issaragrisil S, le Coutre P, et al. Long-term outcomes with frontline nilotinib versus imatinib in newly diagnosed chronic myeloid leukemia in chronic phase: ENESTnd 10-year analysis. Leukemia. 2021;35(2):440–53.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Brummendorf TH, Cortes JE, Milojkovic D, Gambacorti-Passerini C, Clark RE, le Coutre P, et al. Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial. Leukemia. 2022;36(7):1825–33.

Article  PubMed  PubMed Central  Google Scholar 

Jabbour EJ, Cortes JE, Kantarjian HM. Resistance to tyrosine kinase inhibition therapy for chronic myelogenous leukemia: a clinical perspective and emerging treatment options. Clin Lymphoma Myeloma Leuk. 2013;13(5):515–29.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Hoch M, Huth F, Manley PW, Loisios-Konstantinidis I, Combes FP, Li YF, et al. Clinical pharmacology of asciminib: a review. Clin Pharmacokinet. 2024;63(11):1513–28.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Manley PW, Barys L, Cowan-Jacob SW. The specificity of asciminib, a potential treatment for chronic myeloid leukemia, as a myristate-pocket binding ABL inhibitor and analysis of its interactions with mutant forms of BCR-ABL1 kinase. Leuk Res. 2020;98:106458.

Article  CAS  PubMed  Google Scholar 

Hochhaus A, Wang J, Kim DW, Kim DDH, Mayer J, Goh YT, et al. Asciminib in newly diagnosed chronic myeloid leukemia. N Engl J Med. 2024;391(10):885–98.

Article  CAS  PubMed  Google Scholar 

Rea D, Mauro MJ, Boquimpani C, Minami Y, Lomaia E, Voloshin S, et al. A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs. Blood. 2021;138(21):2031–41.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Hochhaus A, Rea D, Boquimpani C, Minami Y, Cortes JE, Hughes TP, et al. Asciminib vs bosutinib in chronic-phase chronic myeloid leukemia previously treated with at least two tyrosine kinase inhibitors: longer-term follow-up of ASCEMBL. Leukemia. 2023;37(3):617–26.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Mauro MJ, Hughes TP, Kim DW, Rea D, Cortes JE, Hochhaus A, et al. Asciminib monotherapy in patients with CML-CP without BCR::ABL1 T315I mutations treated with at least two prior TKIs: 4-year phase 1 safety and efficacy results. Leukemia. 2023;37(5):1048–59.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Li YF, Combes FP, Hoch M, Lorenzo S, Sy SKB, Ho YY. Population pharmacokinetics of asciminib in tyrosine kinase inhibitor-treated patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic and acute phases. Clin Pharmacokinet. 2022;61(10):1393–403.

Article  CAS  PubMed  Google Scholar 

Darstein C, Yoon D, Yang Y, Kapoor S, Dasgupta K, Wu S, et al. Population pharmacokinetic modeling of asciminib in support of exposure-response and ethnic sensitivity analyses in patients with chronic myeloid leukemia. Cancer Chemother Pharmacol. 2025;95(1):39.

Article  CAS  PubMed  Google Scholar 

Giles FJ, Yin OQ, Sallas WM, le Coutre PD, Woodman RC, Ottmann OG, et al. Nilotinib population pharmacokinetics and exposure–response analysis in patients with imatinib-resistant or -intolerant chronic myeloid leukemia. Eur J Clin Pharmacol. 2013;69(4):813–23.

Article  PubMed  Google Scholar 

Larson RA, Yin OQ, Hochhaus A, Saglio G, Clark RE, Nakamae H, et al. Population pharmacokinetic and exposure-response analysis of nilotinib in patients with newly diagnosed Ph+ chronic myeloid leukemia in chronic phase. Eur J Clin Pharmacol. 2012;68(5):723–33.

Article  CAS  PubMed  Google Scholar 

Combes FP, Li YF, Hoch M, Lorenzo S, Ho YY, Sy SKB. Exposure-efficacy analysis of asciminib in Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Clin Pharmacol Ther. 2022;112(5):1040–50.

Article  CAS  PubMed  Google Scholar 

Combes FP, Sy SKB, Li YF, Lorenzo S, Dasgupta K, Kapoor S, et al. Dose justification for asciminib in patients with Philadelphia chromosome-positive chronic myeloid leukemia with and without the T315I mutation. Clin Pharmacokinet. 2024;63(9):1301–12.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Fassoni AC, Baldow C, Roeder I, Glauche I. Reduced tyrosine kinase inhibitor dose is predicted to be as effective as standard dose in chronic myeloid leukemia: a simulation study based on phase III trial data. Haematologica. 2018;103(11):1825–34.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Roeder I, Horn M, Glauche I, Hochhaus A, Mueller MC, Loeffler M. Dynamic modeling of imatinib-treated chronic myeloid leukemia: functional insights and clinical implications. Nat Med. 2006;12(10):1181–4.

Article  CAS  PubMed  Google Scholar 

Michor F, Hughes TP, Iwasa Y, Branford S, Shah NP, Sawyers CL, et al. Dynamics of chronic myeloid leukaemia. Nature. 2005;435(7046):1267–70.

Article  CAS  PubMed  Google Scholar 

Branford S, Kim DW, Soverini S, Haque A, Shou Y, Woodman RC, et al. Initial molecular response at 3 months may predict both response and event-free survival at 24 months in imatinib-resistant or -intolerant patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase treated with nilotinib. J Clin Oncol. 2012;30(35):4323–9.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Sy SKB, Yoon DY, Darstein C, Yang Y, Dasgupta K, Kapoor S, et al. Population modelling of nilotinib exposure vs. longitudinal BCR::ABL1 response in patients with chronic phase chronic myeloid leukaemia using a semimechanistic disease model. Br J Clin Pharmacol. 2025;91(5):1419-30.

Atallah EL, Mauro MJ, Sasaki K, Levy MY, Koller P, Yang D, et al. Dose-escalation of second-line and first-line asciminib in chronic myeloid leukemia in chronic phase: the ASC2ESCALATE phase II trial. Future Oncol. 2024;20(38):3065–75.

Article  CAS  PubMed  Google Scholar 

Atallah EL, Levy MY, Koller PB, Sasaki K, Tantravahi SK, Andorsky D, et al. Efficacy and safety of asciminib in chronic myeloid leukemia in chronic phase (CML-CP): interim results from the phase 2 ASC2ESCALATE trial in the cohort of patients (Pts) after 1 prior tyrosine kinase inhibitor (TKI). Blood. 2024;144:479.

Article  Google Scholar 

Zhao CY, Jiao Z, Mao JJ, Qiu XY. External evaluation of published population pharmacokinetic models of tacrolimus in adult renal transplant recipients. Br J Clin Pharmacol. 2016;81(5):891–907.

Article  CAS