Gemtuzumab Ozogamicin: Time to Resurrect?

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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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Cite This Study

Ravandi et al. (Tue,) studied this question.

synapsesocial.com/papers/6a2284bbb65eef78bdff8e94 https://doi.org/https://doi.org/10.1200/jco.2012.43.0132

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

1Addition of Gemtuzumab Ozogamicin to Induction Chemotherapy Improves Survival in Older Patients With Acute Myeloid Leukemia2012 · 407 citations

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

1Addition of Gemtuzumab Ozogamicin to Induction Chemotherapy Improves Survival in Older Patients With Acute Myeloid Leukemia2012 · 407 citations

2Preliminary Results of Southwest Oncology Group Study S0106: An International Intergroup Phase 3 Randomized Trial Comparing the Addition of Gemtuzumab Ozogamicin to Standard Induction Therapy Versus Standard Induction Therapy Followed by a Second Randomization to Post-Consolidation Gemtuzumab Ozogamicin Versus No Additional Therapy for Previously Untreated Acute Myeloid Leukemia.2009 · 183 citations