Thandra KC, Barsouk A, Saginala K et al (2021) Epidemiology of lung cancer. Contemp Oncol 25(1):45–52
Huang Y, Zhang LJCI (2023) Annual progress of clinical research on targeted therapy for nonsmall cell lung cancer in 2022. Cancer Innovation 2(1):25–35
Coleman N, Hong L, Zhang J et al (2021) Beyond epidermal growth factor receptor: MET amplification as a general resistance driver to targeted therapy in oncogene-driven non-small-cell lung cancer. ESMO Open 6(6):100319
Article CAS PubMed PubMed Central Google Scholar
Farago AF, Taylor MS, Doebele RC et al (2018) Clinicopathologic features of non–small-cell lung cancer harboring an NTRK gene fusion. JCO Precis Oncol 2:1–12
Demetri GD, De Braud F, Drilon A et al (2022) Updated integrated analysis of the efficacy and safety of entrectinib in patients with NTRK fusion-positive solid tumors. Clin Cancer Res.
Gaebe K, Li AY, Das SJC (2021) Clinical biomarkers for early identification of patients with intracranial metastatic disease. Cancers (Basel) 13(23):5973
Article CAS PubMed Google Scholar
Wang Y, Shen S, Hu P et al (2022) Alectinib versus crizotinib in ALK-positive advanced non-small-cell lung cancer and comparison of next-generation TKIs after crizotinib failure: Real-world evidence. Cancer Med 11(23):4491–4500
Article PubMed PubMed Central Google Scholar
Al-Salama ZT, Keam SJJD (2019) Entrectinib: first global approval. Drugs 79(13):1477–1483
Delgado J, Pean E, Melchiorri D et al (2021) The European medicines agency review of entrectinib for the treatment of adult or paediatric patients with solid tumours who have a neurotrophic tyrosine receptor kinase gene fusions and adult patients with non-small-cell lung cancer harbouring ROS1 rearrangements. ESMO Open 6(2):100087
Article CAS PubMed PubMed Central Google Scholar
Dziadziuszko R, Hung T, Wang K et al (2022) Pre-and post-treatment blood-based genomic landscape of patients with ROS1 or NTRK fusion-positive solid tumours treated with entrectinib. Mol Oncol 16(10):2000–2014
Article CAS PubMed PubMed Central Google Scholar
Food and Drug Administration (FDA). Available online: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212725Orig1s000,%20212726Orig1s000MultidisciplineR.pdf (accessed on 1, May, 2023).
Georgi V, Schiele F, Berger B-T et al (2018) Binding kinetics survey of the drugged kinome. J Am Chem Soc 140(46):15774–15782
Article CAS PubMed Google Scholar
Xu L, Yu S, Liu H et al (2022) Physiologically based pharmacokinetic combined BTK occupancy modeling for optimal dosing regimen prediction of acalabrutinib in patients alone, with different CYP3A4 variants, co-administered with CYP3A4 modulators and with hepatic impairment. Eur J Clin Pharmacol 78(9):1435–1446
Article CAS PubMed Google Scholar
Yamazaki SJTAJ (2013) Translational pharmacokinetic-pharmacodynamic modeling from nonclinical to clinical development: a case study of anticancer drug, crizotinib. AAPS J 15:354–366
Yamamoto Y, Välitalo PA, Huntjens DR et al (2017) Predicting drug concentration-time profiles in multiple CNS compartments using a comprehensive physiologically-based pharmacokinetic model. CPT Pharmacometrics Syst Pharmacol 6(11):765–777
Article CAS PubMed PubMed Central Google Scholar
Adiwidjaja J, Gross AS, Boddy AV et al (2022) Physiologically-based pharmacokinetic model predictions of inter-ethnic differences in imatinib pharmacokinetics and dosing regimens. Br J Clin Pharmacol 88(4):1735–1750
Article CAS PubMed Google Scholar
Wang Z, Liu W, Li X et al (2022) Physiologically based pharmacokinetic combined JAK2 occupancy modeling to simulate PK and PD of baricitinib with kidney transporter inhibitors and in patients with hepatic/renal impairment. Regul Toxicol Pharmacol 133:105210
Article CAS PubMed Google Scholar
Alsmadi MtM, AL‐Daoud NM, Jaradat MM, et al (2021) Physiologically‐based pharmacokinetic model for alectinib, ruxolitinib, and panobinostat in the presence of cancer, renal impairment and hepatic impairment. Biopharm Drug Dispos 42 (6): 263-284
Djebli N, Buchheit V, Parrott N et al (2021) Physiologically-based pharmacokinetic modeling of entrectinib parent and active metabolite to support regulatory decision-making. Eur J Drug Metab Pharmacokinet 46:779–791
Article CAS PubMed Google Scholar
Pharmaceuticals and Medical Devices Agency (PMDA). Available online: https://www.info.pmda.go.jp/go/interview/1/450045_4291061M1025_1_008_1F.pdf (accessed on 1, May, 2023).
Parrott N, Stillhart C, Lindenberg M et al (2020) Physiologically based absorption modelling to explore the impact of food and gastric pH changes on the pharmacokinetics of entrectinib. AAPS J 22:1–13
Menichincheri M, Ardini E, Magnaghi P et al (2016) Discovery of entrectinib: a new 3-aminoindazole as a potent anaplastic lymphoma kinase (ALK), c-ros oncogene 1 kinase (ROS1), and pan-tropomyosin receptor kinases (Pan-TRKs) inhibitor. J Med Chem 59(7):3392–3408
Article CAS PubMed Google Scholar
Barter ZE, Tucker GT, Rowland-Yeo KJCp, (2013) Differences in cytochrome p450-mediated pharmacokinetics between chinese and caucasian populations predicted by mechanistic physiologically based pharmacokinetic modelling. Clin Pharmacokinet 52: 1085-1100
Hughes JH, Upton RN, Reuter SE et al (2019) Development of a physiologically based pharmacokinetic model for intravenous lenalidomide in mice. Cancer Chemother Pharmacol 84:1073–1087
Article CAS PubMed PubMed Central Google Scholar
Gao D, Wang G, Wu H et al (2023) Prediction for Plasma Trough Concentration and Optimal Dosing of Imatinib under Multiple Clinical Situations Using Physiologically Based Pharmacokinetic Modeling. ACS Omega.
Drilon A, Siena S, Ou S-HI et al (2017) Safety and antitumor activity of the multitargeted Pan-TRK, ROS1, and ALK inhibitor entrectinib: combined results from two phase I Trials (ALKA-372-001 and STARTRK-1) Entrectinib in NTRK-, ROS1-, or ALK-rearranged cancers. Cancer Discov 7(4):400–409
Article CAS PubMed PubMed Central Google Scholar
Meneses-Lorente G, Bentley D, Guerini E et al (2021) Characterization of the pharmacokinetics of entrectinib and its active M5 metabolite in healthy volunteers and patients with solid tumors. Invest New Drugs 39:803–811
Article CAS PubMed PubMed Central Google Scholar
Meneses-Lorente G, Fowler S, Guerini E et al (2022) In vitro and clinical investigations to determine the drug-drug interaction potential of entrectinib, a small molecule inhibitor of neurotrophic tyrosine receptor kinase (NTRK). Invest New Drugs 40(1):68–80
Article CAS PubMed Google Scholar
Mayr L, Guntner AS, Madlener S et al (2020) Cerebrospinal fluid penetration and combination therapy of entrectinib for disseminated ROS1/NTRK fusion-positive pediatric high-grade glioma. J Pers Med 10(4):290
Article PubMed PubMed Central Google Scholar
Mercier F, Djebli N, González-Sales M et al (2022) Efficacy and safety exposure–response analyses of entrectinib in patients with advanced or metastatic solid tumors. Cancer Chemother Pharmacol 89(3):363–372
Article CAS PubMed Google Scholar
Food and Drug Administration (FDA). Available online: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/210259Orig1s000MultidisciplineR.pdf (accessed on 1, May, 2023).
Salerno SN, Edginton A, Gerhart JG et al (2021) Physiologically-based pharmacokinetic modeling characterizes the CYP3A-mediated drug-drug interaction between fluconazole and sildenafil in infants. Clin Pharmacol Ther 109(1):253–262
Article CAS PubMed Google Scholar
McCormick A, Swaisland H, Reddy VP et al (2018) In vitro evaluation of the inhibition and induction potential of olaparib, a potent poly (ADP-ribose) polymerase inhibitor, on cytochrome P450. Xenobiotica 48(6):555–564
Article CAS PubMed Google Scholar
Kuramoto S, Kato M, Shindoh H et al (2017) Simple evaluation method for CYP3A4 induction from human hepatocytes: the relative factor approach with an induction detection limit concentration based on the Emax model. Drug Metab Dispos 45(11):1139–1145
Article CAS PubMed Google Scholar
Schwenger E, Reddy VP, Moorthy G et al (2018) Harnessing meta-analysis to refine an oncology patient population for physiology-based pharmacokinetic modeling of drugs. Clin Pharmacol Ther 103(2):271–280
Article CAS PubMed Google Scholar
Dixon MR, Haukoos JS, Udani SM et al (2003) Carcinoembryonic antigen and albumin predict survival in patients with advanced colon and rectal cancer. Arch Surg 138(9):962–966
de LangeDanhof ECMJCP (2002) Considerations in the use of cerebrospinal fluid pharmacokinetics to predict brain target concentrations in the clinical setting: implications of the barriers between blood and brain. Clin Pharmacokinet 41:691–703
Yu J, Wang Y, Ragueneau-Majlessi IJDM et al (2022) Pharmacokinetic drug-drug interactions with drugs approved by the US Food and Drug Administration in 2020: mechanistic understanding and clinical recommendations. Drug Metab Dispos 50(1):1–7
Sun C, Nierman P, Kendall EK et al (2020) Clinical and biological implications of target occupancy in CLL treated with the BTK inhibitor acalabrutinib. Blood 136(1):93–105
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