FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia

Oncologist

Volumn 23, Issue 9, 2018, Pages 1103-1108

  Norsworthy, Kelly J ^a   Ko, Chia Wen ^a   Lee, Jee Eun ^a   Liu, Jiang ^a   John, Christy S ^a   Przepiorka, Donna ^a   Farrell, Ann T ^a   Pazdur, Richard ^a  

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

Author keywords

Acute myeloid leukemia; Gemtuzumab ozogamicin; Mylotarg; U.S. Food and Drug Administration approval

Indexed keywords

ABC TRANSPORTER SUBFAMILY B; CD33 ANTIGEN; CYTARABINE; GEMTUZUMAB OZOGAMICIN; MULTIDRUG RESISTANCE PROTEIN 1; AMINOGLYCOSIDE; CD33 PROTEIN, HUMAN; GEMTUZUMAB; MONOCLONAL ANTIBODY;

ACUTE MYELOID LEUKEMIA; AREA UNDER THE CURVE; ARTICLE; BLEEDING; BONE MARROW SUPPRESSION; CLINICAL EVALUATION; CONSTIPATION; CONTROLLED STUDY; CYTOGENETICS; CYTOTOXICITY; DE NOVO ACUTE MYELOID LEUKEMIA; DIARRHEA; DRUG APPROVAL; DRUG SAFETY; DRUG WITHDRAWAL; EFFICACY PARAMETERS; FEVER; FOOD AND DRUG ADMINISTRATION; HEADACHE; HUMAN; HYPERTRANSAMINASEMIA; INFECTION; LIVER TOXICITY; LOW DRUG DOSE; LUNG EDEMA; META ANALYSIS; MONOTHERAPY; MORBIDITY; MORTALITY; MUCOSA INFLAMMATION; NAUSEA AND VOMITING; NEUTROPHIL; ONCOLOGIST; OUTCOME ASSESSMENT; PAIN; PNEUMONIA; PRIORITY JOURNAL; PROGNOSTIC ASSESSMENT; PROTEIN EXPRESSION; PUBLICATION; RANDOMIZED CONTROLLED TRIAL; RASH; RECURRENCE FREE SURVIVAL; REFRACTORY PERIOD; SYSTEMATIC REVIEW; TACHYCARDIA; VEIN OCCLUSION; ADULT; AGED; GENETICS; METABOLISM; MIDDLE AGED; PATHOLOGY; UNITED STATES; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; AMINOGLYCOSIDES; ANTIBODIES, MONOCLONAL, HUMANIZED; HUMANS; LEUKEMIA, MYELOID, ACUTE; MIDDLE AGED; SIALIC ACID BINDING IG-LIKE LECTIN 3; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; YOUNG ADULT;

EID: 85048163293     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2017-0604     Document Type: Article

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