Approval probabilities and regulatory review patterns for anticancer drugs in the European Union

Critical Reviews in Oncology/Hematology

Volumn 87, Issue 2, 2013, Pages 112-121

  Hartmann, Markus ^a   Mayer Nicolai, Christine ^b   Pfaff, Otmar ^b  

^a European Consulting and Contracting in Oncology   (Germany)

^b MERCK KGAA   (Germany)

Author keywords

Anticancer drug approval; Approval probability; Drug approval; Drug evaluation; European Medicines Agency; Marketing authorization application; Neoplasms; Regulatory review pattern

Indexed keywords

ABIRATERONE ACETATE; ANTINEOPLASTIC AGENT; AZACITIDINE; CABAZITAXEL; CATUMAXOMAB; CLOFARABINE; DASATINIB; DEGARELIX; ERIBULIN; EVEROLIMUS; GEFITINIB; GIMERACIL PLUS OTERACIL POTASSIUM PLUS TEGAFUR; IPILIMUMAB; LAPATINIB; LENALIDOMIDE; MIFAMURTIDE; NELARABINE; NILOTINIB; OFATUMUMAB; PACLITAXEL; PANITUMUMAB; PAZOPANIB; PLERIXAFOR; SORAFENIB; SUNITINIB; TEMSIROLIMUS; THALIDOMIDE; TRABECTEDIN; UNINDEXED DRUG; VINFLUNINE;

ACUTE LYMPHOBLASTIC LEUKEMIA; ADJUVANT THERAPY; BREAST CANCER; BREAST METASTASIS; CHRONIC LYMPHATIC LEUKEMIA; CHRONIC MYELOID LEUKEMIA; CLINICAL TRIAL (TOPIC); COLORECTAL CANCER; COMPARATIVE STUDY; DECISION MAKING; DRUG APPROVAL; DRUG MARKETING; EUROPEAN UNION; GASTROINTESTINAL STROMAL TUMOR; HEMATOLOGIC MALIGNANCY; HUMAN; JAPAN; KIDNEY CANCER; KIDNEY CARCINOMA; LUNG NON SMALL CELL CANCER; LYMPHOBLASTOMA; MALIGNANT ASCITES; MELANOMA; MULTIPLE MYELOMA; MYELODYSPLASTIC SYNDROME; OSTEOSARCOMA; OVERALL SURVIVAL; PROBABILITY; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SARCOMA; STOMACH CANCER; T CELL ACUTE LYMPHOBLASTIC LEUKEMIA; T CELL LYMPHOBLASTIC LYMPHOMA; TREATMENT OUTCOME; UNITED STATES; UROGENITAL TRACT CANCER;

ANTICANCER DRUG APPROVAL; APPROVAL PROBABILITY; DRUG APPROVAL; DRUG EVALUATION; EUROPEAN MEDICINES AGENCY; MARKETING AUTHORIZATION APPLICATION; NEOPLASMS; REGULATORY REVIEW PATTERN;

ANTINEOPLASTIC AGENTS; DRUG APPROVAL; EUROPEAN UNION; HUMANS;

EID: 84881235007     PISSN: 10408428     EISSN: 18790461     Source Type: Journal    
DOI: 10.1016/j.critrevonc.2013.01.004     Document Type: Review

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