Crump M, Neelapu SS, Farooq U, Van Den Neste E, Kuruvilla J, Westin J, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130:1800–8.
Article CAS PubMed PubMed Central Google Scholar
Hutchings M. The evolving therapy of DLBCL: bispecific antibodies. Hematol Oncol. 2023;41(S1):107–11.
Barraclough A, Hawkes E, Sehn LH, Smith SM. Diffuse large B-cell lymphoma. Hematol Oncol. 2024;42:e3202.
Article PubMed PubMed Central Google Scholar
Jain T, Bar M, Kansagra AJ, Chong EA, Hashmi SK, Neelapu SS, et al. Use of chimeric antigen receptor T cell therapy in clinical practice for relapsed/refractory aggressive B cell non-Hodgkin lymphoma: an expert panel opinion from the American Society for Transplantation and Cellular Therapy. Biol Blood Marrow Transplant. 2019;25:2305–21.
Article CAS PubMed Google Scholar
Epkinly [package insert]. Plainsboro: Genmab US, Inc.; 2024.
van der Horst HJ, de Jonge AV, Hiemstra IH, Gelderloos AT, Berry DRAI, Hijmering NJ, et al. Epcoritamab induces potent anti-tumor activity against malignant B-cells from patients with DLBCL, FL and MCL, irrespective of prior CD20 monoclonal antibody treatment. Blood Cancer J. 2021;11:38.
Article PubMed PubMed Central Google Scholar
Tepkinly [summary of product characteristics]. Ludwigshafen: AbbVie Deutschland GmbH & Co. KG; 2024.
Epkinly [Japan package insert]. Tokyo: AbbVie GK, Genmab K.K.; 2023.
Epkinly [Canada product monograph]. St-Laurent: AbbVie Corporation; 2023.
Tepkinly [UK summary of product characteristics]. Maidenhead: AbbVie; 2023.
Engelberts PJ, Hiemstra IH, de Jong B, Schuurhuis DH, Meesters J, Beltran Hernandez I, et al. DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing. EBioMedicine. 2020;52:102625.
Article PubMed PubMed Central Google Scholar
Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, et al. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021;398:1157–69.
Article CAS PubMed Google Scholar
Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, et al. Epcoritamab, a novel, subcutaneous CD3xCD20 bispecific T-cell-engaging antibody, in relapsed or refractory large B-cell lymphoma: dose expansion in a phase I/II trial. J Clin Oncol. 2023;41:2238–47.
Article CAS PubMed Google Scholar
Izutsu K, Kumode T, Yuda J, Nagai H, Mishima Y, Suehiro Y, et al. Subcutaneous epcoritamab monotherapy in Japanese adults with relapsed/refractory diffuse large B-cell lymphoma. Cancer Sci. 2023;114:4643–53.
Article CAS PubMed PubMed Central Google Scholar
Li T, Hiemstra IH, Chiu C, Oliveri RS, Elliott B, DeMarco D, et al. Semimechanistic physiologically-based pharmacokinetic/pharmacodynamic model informing epcoritamab dose selection for patients with B-cell lymphomas. Clin Pharmacol Ther. 2022;112:1108–19.
Article CAS PubMed PubMed Central Google Scholar
Bioanalytical method validation: guidance for industry. 2018. https://www.fda.gov/media/70858/download. Accessed 11 Sept 2024.
European Medicines Agency. Guideline on bioanalytical method validation. 2011. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf. Accessed 11 Sept 2024.
European Medicines Agency. ICH guideline M10 on bioanalytical method validation and study sample analysis step 5. 2022. https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-m10-bioanalytical-method-validation-step-5_en.pdf. Accessed 11 Sept 2024.
Briggs RJ, Nicholson R, Vazvaei F, Busch J, Mabuchi M, Mahesh KS, et al. Method transfer, partial validation, and cross validation: recommendations for best practices and harmonization from the global bioanalysis consortium harmonization team. AAPS J. 2014;16:1143–8.
Article CAS PubMed PubMed Central Google Scholar
DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, Lee B, et al. Recommendations for the bioanalytical method validation of ligand-binding assays to support pharmacokinetic assessments of macromolecules. Pharm Res. 2003;20:1885–900.
Article CAS PubMed Google Scholar
Findlay JWA, Smith WC, Lee JW, Nordblom GD, Das I, DeSilva BS, et al. Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective. J Pharm Biomed Anal. 2000;21:1249–73.
Article CAS PubMed Google Scholar
European Medicines Agency. Guideline on immunogenicity assessment of therapeutic proteins. 2017. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-immunogenicity-assessment-therapeutic-proteins-revision-1_en.pdf. Accessed 23 Sept 2024.
Immunogenicity testing of therapeutic protein products — developing and validating assays for anti-drug antibody detection: guidance for industry. 2019. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/immunogenicity-testing-therapeutic-protein-products-developing-and-validating-assays-anti-drug. Accessed 23 Sept 2024.
NONMEM User's Guide. San Francisco: University of California, San Francisco, NONMEM Project Group; 1992.
Gibiansky L, Gibiansky E, Kakkar T, Ma P. Approximations of the target-mediated drug disposition model and identifiability of model parameters. J Pharmacokinet Pharmacodyn. 2008;35:573–91.
Article CAS PubMed Google Scholar
Mager DE, Jusko WJ. General pharmacokinetic model for drugs exhibiting target-mediated drug disposition. J Pharmacokinet Pharmacodyn. 2001;28:507–32.
Article CAS PubMed Google Scholar
Bergstrand M, Hooker AC, Wallin JE, Karlsson MO. Prediction-corrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J. 2011;13:143–51.
Article PubMed PubMed Central Google Scholar
Brendel K, Comets E, Laffont C, Laveille C, Mentré F. Metrics for external model evaluation with an application to the population pharmacokinetics of gliclazide. Pharm Res. 2006;23:2036–49.
Article CAS PubMed PubMed Central Google Scholar
Mentré F, Escolano S. Prediction discrepancies for the evaluation of nonlinear mixed-effects models. J Pharmacokinet Pharmacodyn. 2006;33:345–67.
Lim K, Zhu XS, Zhou D, Ren S, Phipps A. Clinical pharmacology strategies for bispecific antibody development: learnings from FDA-approved bispecific antibodies in oncology. Clin Pharmacol Ther. 2024;116:315–27.
Article CAS PubMed Google Scholar
Clements JD, Zhu M, Kuchimanchi M, Terminello B, Doshi S. Population pharmacokinetics of blinatumomab in pediatric and adult patients with hematological malignancies. Clin Pharmacokinet. 2020;59:463–74.
Article CAS PubMed Google Scholar
NDA/BLA multi-disciplinary review and evaluation BLA 761228: Kimmtrak (tebentafusp). 2022. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761228Orig1s000MultidisciplineR.pdf. Accessed 3 Sept 2024.
Miao X, Wu LS, Lin SXW, Xu Y, Chen Y, Iwaki Y, et al. Population pharmacokinetics and exposure–response with teclistamab in patients with relapsed/refractory multiple myeloma: results from MajesTEC-1. Target Oncol. 2023;18:667–84.
Article PubMed PubMed Central Google Scholar
Bender B, Li CC, Marchand M, Turner DC, Li F, Vadhavkar S, et al. Population pharmacokinetics and CD20 binding dynamics for mosunetuzumab in relapsed/refractory B-cell non-Hodgkin lymphoma. Clin Transl Sci. 2024;17: e13825.
Article CAS PubMed PubMed Central Google Scholar
Djebli N, Morcos PN, Jaminion F, Guerini E, Kratochwil NA, Justies N, et al. Population pharmacokinetics and exposure-response analyses for glofitamab in relapsed/refractory B-cell non-Hodgkin lymphoma (R/R NHL): confirmation of efficacy and CRS mitigation in patients with step-up dosing [abstract]. Blood. 2020;136(suppl 1):1–2.
Gibiansky L, Sutjandra L, Doshi S, Zheng J, Sohn W, Peterson MC, et al. Population pharmacokinetic analysis of denosumab in patients with bone metastases from solid tumours. Clin Pharmacokinet. 2012;51:247–60.
Article CAS PubMed Google Scholar
Gibiansky L, Gibiansky E. Target-mediated drug disposition model for drugs that bind to more than one target. J Pharmacokinet Pharmacodyn. 2010;37:323–46.
Article CAS PubMed Google Scholar
Dirks NL, Meibohm B. Population pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49:633–59.
Article CAS PubMed Google Scholar
Agoram B, Sutjandra L, Sullivan JT. Population pharmacokinetics of darbepoetin alfa in healthy subjects. Br J Clin Pharmacol. 2007;63:41–52.
Comments (0)