A fresh perspective on comparing the FDA and the CHMP/EMA: Approval of antineoplastic tyrosine kinase inhibitors

British Journal of Clinical Pharmacology

Volumn 76, Issue 3, 2013, Pages 396-411

  Shah, Rashmi R ^a   Roberts, Samantha A ^b   Shah, Devron R ^a  

^a Rashmi Shah Consultancy Ltd   (United Kingdom)

^b Friends of Cancer Research   (United States)

Author keywords

Accelerated approval; Conditional approval; EMA; FDA; Priority review; Tyrosine kinase inhibitors

Indexed keywords

AXITINIB; BOSUTINIB; CRIZOTINIB; DASATINIB; ERLOTINIB; GEFITINIB; IMATINIB; LAPATINIB; PAZOPANIB; PROTEIN TYROSINE KINASE INHIBITOR; REGORAFENIB; RUXOLITINIB; SORAFENIB; SUNITINIB; VANDETANIB; VEMURAFENIB;

ACUTE LYMPHOBLASTIC LEUKEMIA; ARTICLE; BREAST CANCER; CANCER SURVIVAL; CHRONIC MYELOID LEUKEMIA; COLORECTAL CANCER; COMPARATIVE STUDY; COST EFFECTIVENESS ANALYSIS; DRUG APPROVAL; DRUG MARKETING; DRUG SAFETY; EUROPEAN UNIONS EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL STROMAL TUMOR; HEALTH CARE ORGANIZATION; HUMAN; HYPEREOSINOPHILIC SYNDROME; KIDNEY CARCINOMA; LAW; LIVER CELL CARCINOMA; LUNG NON SMALL CELL CANCER; MELANOMA; MYELODYSPLASTIC SYNDROME; MYELOFIBROSIS; OVERALL SURVIVAL; PANCREAS CANCER; PANCREATIC NEUROENDOCRINE TUMOR; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; REIMBURSEMENT; RISK ASSESSMENT; SOFT TISSUE SARCOMA; THYROID MEDULLARY CARCINOMA;

ACCELERATED APPROVAL; CONDITIONAL APPROVAL; EMA; FDA; PRIORITY REVIEW; TYROSINE KINASE INHIBITORS;

ANTINEOPLASTIC AGENTS; DRUG APPROVAL; EUROPEAN UNION; GOVERNMENT AGENCIES; HUMANS; NEOPLASMS; PROTEIN KINASE INHIBITORS; PROTEIN-TYROSINE KINASES; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84877137384     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/bcp.12085     Document Type: Article

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