Dose optimization of single-agent inotuzumab ozogamicin in adults with relapsed/refractory acute lymphoblastic leukemia.

Authors

Daniel J DeAngelo, Ying Chen, Ryan D Cassaday, Jennifer E Hibma, Derek Z Yang, May Garrett, Fan Zhang, Svetoslav H Dimitrov, Erik R Vandendries, Hagop M Kantarjian

Published in

Leukemia & lymphoma. Pages 1-11. Aug 18, 2026. Epub Aug 18, 2026.

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.

PMID:
42611806
Bibliographic data and abstract were imported from PubMed on 19 Aug 2026.

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