U.S. Food and Drug Administration approval: Obinutuzumab in combination with chlorambucil for the treatment of previously untreated chronic lymphocytic leukemia

Clinical Cancer Research

Volumn 20, Issue 15, 2014, Pages 3902-3907

  Lee, Hyon Zu ^a   Miller, Barry W ^a   Kwitkowski, Virginia E ^a   Ricci, Stacey ^a   Del Valle, Pedro ^a   Saber, Haleh ^a   Grillo, Joseph ^b   Bullock, Julie ^b   Florian, Jeffry ^b   Mehrotra, Nitin ^b   Ko, Chia Wen ^b   Nie, Lei ^b   Shapiro, Marjorie ^b   Tolnay, Mate ^b   Kane, Robert C ^a   Kaminskas, Edvardas ^a   Justice, Robert ^a   Farrell, Ann T ^a   Pazdur, Richard ^a  

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

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

Author keywords

[No Author keywords available]

Indexed keywords

ANTIHISTAMINIC AGENT; CD20 ANTIGEN; CHLORAMBUCIL; GLUCOCORTICOID; OBINUTUZUMAB; PARACETAMOL; RITUXIMAB; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY;

ADULT; AGED; ANEMIA; ARTHRALGIA; BONE MARROW SUPPRESSION; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CHILL; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL PHARMACOLOGY; CONTROLLED STUDY; COUGHING; DRUG APPROVAL; DRUG DISTRIBUTION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MECHANISM; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FEVER; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPOTENSION; INFUSION RELATED REACTION; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL PAIN; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY; RANDOMIZED CONTROLLED TRIAL; REVIEW; RISK BENEFIT ANALYSIS; STUDY DESIGN; SURVIVAL RATE; SURVIVAL TIME; THROMBOCYTOPENIA; TUMOR LYSIS SYNDROME; VERY ELDERLY; CLINICAL TRIAL; FOLLOW UP; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MORTALITY; PROGNOSIS; UNITED STATES;

AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHLORAMBUCIL; DRUG APPROVAL; FEMALE; FOLLOW-UP STUDIES; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; PROGNOSIS; SURVIVAL RATE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84905506991     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-14-0516     Document Type: Review

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