Dose optimization of single-agent inotuzumab ozogamicin in adults with relapsed/refractory acute lymphoblastic leukemia
Year: 2026
Type: review
Abstract: Following the approval of inotuzumab ozogamicin (InO) monotherapy for the treatment of adults with relapsed/refractory CD22-positive acute lymphoblastic leukemia, the US Food and Drug Administration issued a post-marketing requirement study due to their concerns that the proposed dose of 1.8 mg/m2/cycle may not be optimal in balancing the safety and efficacy of InO. Here, we provide an overview of single-agent InO dose-optimization strategies, including the rationale for studying a fractionated InO dosing schedule and justification for the approved dosing regimen based on clinical safety and efficacy data, as well as comprehensive exposure–response analyses from InO clinical studies.
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Funder: Pfizer
OpenAlex ID: W7203702655