Artigo Acesso aberto Revisado por pares

Gemtuzumab Ozogamicin: Time to Resurrect?

2012; Lippincott Williams & Wilkins; Volume: 30; Issue: 32 Linguagem: Inglês

10.1200/jco.2012.43.0132

ISSN

1527-7755

Autores

Farhad Ravandi, Elihu H. Estey, Frederick R. Appelbaum, Francesco Lo‐Coco, Charles A. Schiffer, Richard A. Larson, Alan K. Burnett, Hagop M. Kantarjian,

Tópico(s)

Multiple Myeloma Research and Treatments

Resumo

On May 17, 2000, the US Food and Drug Administration (FDA) granted accelerated approval for the use of gemtuzumab ozogamicin (GO) in older patients (age ≥ 60 years) with acute myeloid leukemia (AML) in first relapse who were not considered candidates for standard cytotoxic chemotherapy.1 Approval for this novel anti-CD33 immunoconjugate was based on a phase II trial demonstrating a 30% response rate (including complete response [CR] and CR with incomplete platelet recovery)2 and was conditional on future demonstration of benefit in treatment of AML. Over the past 10 years, several phase II and III trials have addressed this issue.

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