Gemtuzumab ozogamicin for the treatment of acute myeloid leukemia in adults. (3rd July 2021)

• Record Type: Journal Article
• Authors: Goldenson, Benjamin H.; Goodman, Aaron M.; Ball, Edward D.
• Is Part Of: Expert opinion on biological therapy. Volume 21:Number 7(2021)
• Page Start: 849
• Page End: 862
• Publication Date: 2021-07-03
• Subjects: Gemtuzumab ozogamicin -- acute myeloid leukemia -- acute promyelocytic leukemia -- venous occlusive disease -- allogeneic hematopoietic stem cell transplant; Gene therapy -- Periodicals; Protein drugs -- Periodicals; Peptide drugs -- Periodicals; Immunotherapy -- Periodicals; Drug delivery systems -- Periodicals; 615.5
• DOI: 10.1080/14712598.2021.1825678
• Languages: English
• ISSNs: 1471-2598

Abstract

ABSTRACT: Introduction: Treatment of acute myeloid leukemia (AML) has changed dramatically in the past ten years with the approval of targeted agents, the first of which was the anti-CD33 antibody-drug conjugate gemtuzumab ozogamicin (GO). Despite withdrawal from the market after accelerated approval, GO was reapproved and now has a well-established role in treating select AML patients. CD33 has proven to be an important target for drug development in AML as evidenced by the improvement in survival with GO treatment. Areas covered: The review summarizes the development of GO, its mechanism of action, initial studies and approval, withdrawal from the market, and subsequent reapproval after the results of several large randomized studies became available. We also provide an overview of its current role in the treatment landscape of AML. Expert opinion: Multiple phase 3 trials with GO have established a significant benefit with GO in induction therapy for favorable risk AML. Additional studies support the use of GO in relapsed/refractory AML and APL. Despite the withdrawal of GO from the market after initial approval, GO has proven to improve survival of select AML patients when added to induction chemotherapy and in relapsed disease.