Post-marketing surveillance of quizartinib for relapsed or refractory FLT3-ITD-positive acute myeloid leukemia in Japan
Abstract
Quizartinib is an oral, once-daily, highly potent and selective second-generation, type II FMS-like tyrosine kinase 3 (FLT3) inhibitor, approved for the treatment of newly diagnosed and relapsed/refractory (R/R) FLT3-internal tandem duplication (ITD)-positive acute myeloid leukemia (AML). This descriptive, observational post-marketing surveillance (PMS) investigated the safety of quizartinib in patients with R/R FLT3-ITD-positive AML who initiated quizartinib between October 2019 and December 2021 in Japan. The safety analysis dataset included 126 patients (mean age 60.4 years) who consented to data publication. Eighty patients (63.5%) had previously received another FLT3 inhibitor. The median treatment duration was 71.0 days. Adverse drug reactions (ADRs) occurred in 68 patients (54.0%); grade ≥ 3 and serious ADRs occurred in 44 (34.9%) and 20 (15.9%) patients, respectively. QT interval prolongation occurred in 18/124 patients (14.5%), and the first event typically occurred < 30 days, but sometimes ≥ 150 days, after quizartinib initiation; none of these patients experienced clinical symptoms associated with the ADR. This PMS showed that the safety profile of quizartinib in routine clinical practice in Japanese patients with R/R FLT3-ITD-positive AML did not differ from the known safety profile of quizartinib. QT interval prolongation was manageable with current risk minimization measures.
Read the paper
Related studies
- Synthesis, In Vitro and In Silico Molecular Docking Studies of Novel Phthalimide–Pyrimidine Hybrid Analogues to Thalidomide as Potent Antitubercular Agents
- Exploring the inhibitory performance of expired moxifloxacin and norfloxacin on copper corrosion in saline environment
- Molecular investigation of antimicrobial peptides against Helicobacter pylori proteins using a peptide-protein docking approach
- Screening of novel narrow-spectrum benzofuroxan derivatives for the treatment of multidrug-resistant tuberculosis through in silico, in vitro, and in vivo approaches
- Synthesis, Characterization, Anticancer, Antioxidant, and In Silico Evaluation of Semicarbazides and Thiosemicarbazides
- Fast and accurate prediction of drug induced proarrhythmic risk with sex specific cardiac emulators
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.