FDA review summary: Mozobil in combination with granulocyte colony-stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation

Oncology

Volumn 78, Issue 3-4, 2010, Pages 282-288

  Brave, Michael ^a,c   Farrell, Ann ^a   Ching Lin, Sue ^b   Ocheltree, Terrance ^b   Pope Miksinski, Sarah ^b   Lee, Shwu Luan ^a   Saber, Haleh ^a   Fourie, Jeanne ^c   Tornoe, Christoffer ^c   Booth, Brian ^c   Yuan, Weishi ^c   He, Kun ^c   Justice, Robert ^a   Pazdur, Richard ^a  

^a Office of New Drugs   (United States)

^b Office of Pharmaceutical Science   (United States)

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

Author keywords

Granulocyte colony stimulating factor; Hematopoietic stem cells; Plerixafor

Indexed keywords

GRANULOCYTE COLONY STIMULATING FACTOR; PLERIXAFOR;

APHERESIS; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION; AUTOTRANSPLANTATION; BLOOD; CD34 SELECTION; CLINICAL TRIAL; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; DRUG STRUCTURE; FATIGUE; FLATULENCE; FOOD AND DRUG ADMINISTRATION; HEADACHE; HEMATOPOIETIC STEM CELL; HUMAN; INJECTION SITE REACTION; INSOMNIA; MAXIMUM PLASMA CONCENTRATION; MULTIPLE MYELOMA; NAUSEA; NONHODGKIN LYMPHOMA; OUTCOME ASSESSMENT; PHARMACODYNAMICS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; SPLENOMEGALY; STEM CELL MOBILIZATION; TREATMENT OUTCOME; VOMITING;

ADULT; AGED; ANTIGENS, CD34; CLINICAL TRIALS AS TOPIC; FEMALE; GRANULOCYTE COLONY-STIMULATING FACTOR; HEMATOPOIETIC STEM CELL MOBILIZATION; HETEROCYCLIC COMPOUNDS; HUMANS; LYMPHOMA, NON-HODGKIN; MALE; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; MULTIPLE MYELOMA; PLACEBOS; PRODUCT SURVEILLANCE, POSTMARKETING; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECEPTORS, CXCR4; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77953125223     PISSN: 00302414     EISSN: None     Source Type: Journal    
DOI: 10.1159/000315736     Document Type: Article

References (18)

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