Population Pharmacokinetics of Inotuzumab Ozogamicin in Pediatric Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia: Results of Study ITCC-059.
Jen-Hao WuEdoardo PennesiFrancisco BautistaMay GarrettKei FukuharaErica BrivioAnneke C J AmmerlaanFranco LocatelliInge M van der SluisClaudia RossigChristiane Chen-SantelBella BieloraiArnaud PetitJan StarýCristina Díaz-de-HerediaSusana RivesAengus O'MarcaighCarmelo RizzariGernot EngstlerKarsten NysomAlba Rubio-San-SimónBenedicte BrunoYves BertrandBenoît BrethonFanny RiallandGeneviève PlatUta DirksenLucie SramkovaChristian Michel ZwaanAlwin D R HuitemaPublished in: Clinical pharmacokinetics (2024)
The pharmacokinetic profile of inotuzumab ozogamicin in pediatric patients with relapsed/refractory BCP-ALL was well described in this study. No dose adjustment is required clinically for pediatric patients with BCP-ALL based on the simulated inotuzumab ozogamicin exposure at the recommended pediatric phase II dose, promising efficacy and acceptable tolerability.