Gemtuzumab ozogamicin

Journal of Clinical Oncology

Volumn 31, Issue 13, 2013, Pages 1699-1700

  Przepiorka, Donna ^a   Deisseroth, Albert ^a   Kane, Robert ^a   Kaminskas, Edvardas ^a   Farrell, Ann T ^a   Pazdur, Richard ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL PRODUCT; CD33 ANTIGEN; CYTARABINE; DAUNORUBICIN; GEMTUZUMAB OZOGAMICIN; AMINOGLYCOSIDE; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ACUTE GRANULOCYTIC LEUKEMIA; ADD ON THERAPY; CONSOLIDATION CHEMOTHERAPY; CYTOGENETICS; DEATH; DRUG APPROVAL; DRUG EFFICACY; DRUG MARKETING; DRUG SAFETY; EVENT FREE SURVIVAL; FOOD AND DRUG ADMINISTRATION; HUMAN; INDUCTION CHEMOTHERAPY; LETTER; LEUKEMIA RELAPSE; OVERALL SURVIVAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENCE FREE SURVIVAL; SIDE EFFECT; TREATMENT RESPONSE; FEMALE; MALE; MORTALITY; MYELODYSPLASTIC SYNDROME; NOTE;

AMINOGLYCOSIDES; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; FEMALE; HUMANS; LEUKEMIA, MYELOID, ACUTE; MALE; MYELODYSPLASTIC SYNDROMES;

EID: 84884558598     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2012.48.1887     Document Type: Letter

References (8)

1. US Food and Drug Administration: Accelerated approval of new drugs for serious or life-threatening illnesses. Code of Federal Regulations, Title 21, Part 314, Subpart H, December 11, 1992
2. Bross PF, Beitz J, Chen G, et al: Approval summary: Gemtuzumab ozogamicin in relapsed acute myeloid leukemia. Clin Cancer Res 7:1490-1496, 2001
3. Petersdorf S, Kopecky K, Stuart RK, et al: Preliminary 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. 51st Annual Meeting and Exposition of the American Society of Hematology, New Orleans, LA, December 5-8, 2009 (abstr 790)
4. Burnett AK, Russell NH, Hills RK, et al: Addition of gemtuzumab ozogamicin to induction chemotherapy improves survival in older patients with acute myeloid leukemia. J Clin Oncol 30:3924-3931, 2012
5. Neuberg DS: Reprise: Gemtuzumab ozogamicin for older patients with acute myeloid leukemia. J Clin Oncol 30:3905-3906, 2012
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7. Ravandi F, Estey EH, Appelbaum FR, et al: Gemtuzumab ozogamicin: Time to resurrect? J Clin Oncol 30:3921-3923, 2012
8. US Food and Drug Administration: Expanded access to investigational drugs for treatment use. Code of Federal Regulations, Title 21, Part 312, Subpart I, August 13, 2009