FDA Approval: Gemtuzumab Ozogamicin for the Treatment of Adults with Newly Diagnosed CD33-Positive Acute Myeloid Leukemia

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منابع مشابه

Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia.

PURPOSE Gemtuzumab ozogamicin (Mylotarg; Wyeth Laboratories, Philadelphia, PA) consists of a semisynthetic derivative of calicheamicin, a cytotoxic antibiotic linked to a recombinant monoclonal antibody directed against the CD33 antigen present on leukemic myeloblasts in most patients with acute myeloid leukemia (AML). In this study, we review the preclinical and clinical profiles of this immun...

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Gemtuzumab ozogamicin in the treatment of adult acute myeloid leukemia

Gemtuzumab ozogamicin (GO) is a humanized anti-CD33 monoclonal antibody conjugated to a derivative of an antitumor antibiotic, calicheamicin. GO was approved for the treatment of relapsed acute myeloid leukemia (AML) in the United States (US) in 2000. However, GO was withdrawn from the US market in June 2010, because a large-scale clinical trial failed to show additive or synergistic effects wi...

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Gemtuzumab ozogamicin and olaparib exert synergistic cytotoxicity in CD33-positive HL-60 myeloid leukemia cells.

BACKGROUND/AIM Gemtuzumab ozogamicin (GO) consists of the cluster of differentiation 33 (CD33) antibody linked to calicheamicin. The binding of GO to the CD33 antigen on leukemic cells results in internalization and subsequent release of calicheamicin, thereby inducing DNA strand breaks. We hypothesized that the poly (ADP-ribose) polymerase inhibitor olaparib might inhibit DNA repair initiated ...

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Targeted treatment of acute myeloid leukemia in older adults: role of gemtuzumab ozogamicin

As the overall prognosis and treatment response rate to standard chemotherapy for acute myeloid leukemia (AML) remains poor in the older adult population, there is a need for more effective therapeutic agents with lower toxicity profiles that can be offered to these patients. Gemtuzumab ozogamicin (GO) is an anti-CD33 monoclonal antibody that was approved by the US Food and Drug Administration ...

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The level of blast CD33 expression positively impacts the effect of gemtuzumab ozogamicin in patients with acute myeloid leukemia.

Laboratoire d’Hématologie et Unité Mixte de Recherche 7276 Centre National de la Recherche Scientifique, Centre Hospitalier Universitaire (CHU) de Limoges, Faculté de Médecine, Université de Limoges et Centre National de la Recherche Scientifique, Limoges, France; Service d’Hématologie Biologique, CHU, Dijon, France; Service d’Hématologie Biologique, Hôpital Saint Antoine, Assistance Publique–H...

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ژورنال

عنوان ژورنال: Clinical Cancer Research

سال: 2018

ISSN: 1078-0432,1557-3265

DOI: 10.1158/1078-0432.ccr-17-3179