A5063691595- Lymphoma Diagnosis and Treatment
- Chronic Lymphocytic Leukemia Research
- Gestational Trophoblastic Disease Studies
- Biochemical and Molecular Research
- Immunodeficiency and Autoimmune Disorders
- Chronic Myeloid Leukemia Treatments
- Reproductive System and Pregnancy
- Ovarian cancer diagnosis and treatment
AbbVie (United States)
2020
Zanubrutinib is a potent, second‐generation Bruton’s tyrosine kinase inhibitor that currently being investigated in patients with B‐cell malignancies and recently received accelerated approval the United States for treatment of relapsed/refractory mantle cell lymphoma. The objective this analysis was to develop population pharmacokinetic (PK) model characterize PKs zanubrutinib identify potential impact intrinsic extrinsic covariates on PK. Data across nine clinical studies data healthy...
BTK inhibitor exposure increases significantly when coadministered with CYP3A inhibitors, which may lead to dose-related toxicities. This study explored the pharmacokinetics, efficacy, and safety of zanubrutinib moderate or strong inhibitors in 26 patients relapsed refractory B-cell malignancies. Coadministration (80 mg BID) fluconazole diltiazem QD) voriconazole resulted comparable exposures (320 AUC0-24h geometric least squares mean ratios approaching 1 (0.94, 0.81, 0.83, for fluconazole,...
Topic: 6. Chronic lymphocytic leukemia and related disorders - Clinical Background: Zanubrutinib (320 mg QD or 160 BID) is a next-generation irreversible Bruton tyrosine kinase (BTK) inhibitor approved in various countries for the treatment of relapsed/refractory (R/R) mantle cell lymphoma (MCL), Waldenström macroglobulinemia (WM), marginal zone (MZL), chronic leukemia/small (CLL/SLL). While both BID doses were studied select phase 1 2 zanubrutinib trials, only dose has been used pivotal...