The European Medicines Agency review of vemurafenib (Zelboraf®) for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use

European Journal of Cancer

Volumn 49, Issue 7, 2013, Pages 1654-1661

  Da Rocha Dias, Silvy ^a   Salmonson, Tomas ^b   Van Zwieten Boot, Barbara ^c   Jonsson, Bertil ^b   Marchetti, Serena ^d   Schellens, Jan H M ^d,e   Giuliani, Rosa ^a   Pignatti, Francesco ^a  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

^b MEDICAL PRODUCTS AGENCY   (Sweden)

^c MEDICINES EVALUATION BOARD   (Netherlands)

^d NETHERLANDS CANCER INSTITUTE   (Netherlands)

^e UTRECHT UNIVERSITY   (Netherlands)

Author keywords

EMA; European Medicines Agency; Melanoma; Vemurafenib

Indexed keywords

AMFEBUTAMONE; B RAF KINASE; DACARBAZINE; MIDAZOLAM; VALINE; VEMURAFENIB;

ALOPECIA; ARTHRALGIA; ARTICLE; BILIARY EXCRETION; CANCER GROWTH; CANCER STAGING; CANCER SURVIVAL; CLINICAL EFFECTIVENESS; DRUG ABSORPTION; DRUG APPROVAL; DRUG ELIMINATION; DRUG ERUPTION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG WITHDRAWAL; FATIGUE; FOLLOW UP; GENE MUTATION; HUMAN; IN VITRO STUDY; IN VIVO STUDY; INOPERABLE CANCER; LIVER FUNCTION; MAXIMUM TOLERATED DOSE; METASTATIC MELANOMA; MULTICENTER STUDY (TOPIC); NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; NONHUMAN; PHARMACOKINETICS; PHARMACOLOGY; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHOTOSENSITIVITY; PRIORITY JOURNAL; QT PROLONGATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECOMMENDED DRUG DOSE; RISK ASSESSMENT; SIDE EFFECT; SKIN CARCINOMA; SQUAMOUS CELL CARCINOMA; STEVENS JOHNSON SYNDROME; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; TREATMENT RESPONSE; URINARY EXCRETION;

CLINICAL TRIALS, PHASE III AS TOPIC; DRUG APPROVAL; DRUG EVALUATION; EUROPEAN UNION; HUMANS; INDOLES; MELANOMA; MUTATION; NEOPLASM METASTASIS; PROTO-ONCOGENE PROTEINS B-RAF; SULFONAMIDES; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 84876130561     PISSN: 09598049     EISSN: 18790852     Source Type: Journal    
DOI: 10.1016/j.ejca.2013.01.015     Document Type: Article

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