Haematological anticancer drugs in Europe: Any added value at the time of approval?

European Journal of Clinical Pharmacology

Volumn 63, Issue 7, 2007, Pages 713-719

  Bertele, Vittorio ^a   Banzi, Rita ^a   Capasso, Filippo ^a   Tafuri, Giovanni ^a   Trotta, Francesco ^a   Apolone, Giovanni ^a   Garattini, Silvio ^a  

^a MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

Author keywords

Added value; EMEA; Endpoint; Haematological anticancer drugs; Regulatory process

Indexed keywords

ALEMTUZUMAB; ALPHA INTERFERON; ALPHA2A INTERFERON; ALPHA2B INTERFERON; ANAGRELIDE; ANTINEOPLASTIC AGENT; ARSENIC TRIOXIDE; BEXAROTENE; BORTEZOMIB; BUSULFAN; CLADRIBINE; CYCLOPHOSPHAMIDE; CYTARABINE; DEXAMETHASONE; DOXORUBICIN; FLUDARABINE; HYDROXYUREA; IBRITUMOMAB TIUXETAN; IMATINIB; LITAK; PENTOSTATIN; PREDNISOLONE; RECOMBINANT ALPHA2B INTERFERON; RETINOID; RITUXIMAB; TENIPOSIDE; TRIMETREXATE; UNCLASSIFIED DRUG; VINCRISTINE;

ALGORITHM; CHRONIC LYMPHATIC LEUKEMIA; CHRONIC MYELOID LEUKEMIA; CLINICAL ASSESSMENT; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CUTANEOUS T CELL LYMPHOMA; DRUG APPROVAL; DRUG COST; DRUG EFFECT; DRUG INDICATION; DRUG RESPONSE; DRUG SCREENING; EUROPE; HAIRY CELL LEUKEMIA; HEMATOLOGIC MALIGNANCY; HUMAN; INFORMATION; LYMPHOMA; MONOTHERAPY; MULTIPLE MYELOMA; NONHODGKIN LYMPHOMA; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROMYELOCYTIC LEUKEMIA; REVIEW; RISK BENEFIT ANALYSIS;

ALGORITHMS; ANTINEOPLASTIC AGENTS; DRUG APPROVAL; EUROPEAN UNION; EVIDENCE-BASED MEDICINE; HEMATOLOGIC NEOPLASMS; HUMANS;

EID: 34250375652     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-007-0296-2     Document Type: Review

References (19)

1. Garattini S, Bertele' V (2002) Efficacy, safety, and cost of new anticancer drugs. Br Med J 325(7358):269-271
2. Apolone G, Joppi R, Bertele' V, Garattini S (2005) Ten years of marketing approvals of anticancer drugs in Europe: regulatory policy and guidance documents need to find a balance between different pressures. Br J Cancer 93:504-509
3. Netzer T (2006) European Union centralised procedure for marketing authorisation of oncology drugs: an in-depth review of its efficiency. Eur J Cancer 42:446-455
4. CPMP/EWP/205/95/Rev. 3 (2005) Guideline on the evaluation of anticancer medicinal products in man. http://www.emea.europa.eu/pdfs/human/ewp/020595en. pdf. Cited 7 Sept 2006
5. National Institute for Clinical Excellence (2002) Guidance on the use of rituximab for recurrent or refractory Stage III or IV follicular non-Hodgkin's lymphoma. National Institute for Clinical Excellence, National Health Service, UK
6. Solal-Celigny P, Lepage E, Brousse N, Tendler CL, Brice P, Haioun C, Gabarre J, Pignon B, Tertian G, Bouabdallah R, Rossi JF, Doyen C, Coiffier B (1998) Doxorubicin-containing regimen with or without interferon alfa-2b for advanced follicular lymphomas: final analysis of survival and toxicity in the Groupe d'Etude des Lymphomes Folliculaires 86 Trial. J Clin Oncol 16:2332-2338
7. Lichtman MA, Beutler E, Kipps T, Seligsohn U, Kaushansky K, Prchal JT (2006) Williams Hematology, 7th edn. McGraw-Hill Medical, London
8. British Committee for Standards in Haematology (2003) Guidelines on the diagnosis and management of chronic lymphocytic leukaemia. British Committee for Standards in Haematology, London
9. Chamberlain MC (2000) Neoplastic meningitis: a guide to diagnosis and treatment. Curr Opin Neurol 13:641-648
10. Whittaker SJ, Marsden JR, Spittle M, Russell Jones R (2003) Joint British Association of Dermatologists and U.K. Cutaneous Lymphoma Group guidelines for the management of primary cutaneous T-cell lymphomas. Br J Dermatol 149:1095-1107
11. Faderl S, Talpaz M, Estrov Z, Kantarjian HM (1999) Chronic myelogenous leukemia: biology and therapy. Ann Intern Med 131:207-219
12. Smith A, Wisloff F, Samson D (2006) Guidelines on the diagnosis and management of multiple myeloma 2005. Br J Haematol 132:410-451
13. Johnson JR, Williams G, Pazdur R (2003) End points and United States food and drug administration approval of oncology drugs. J Clin Oncol 21:1404-1411
14. Kelloff GJ, Sigman CC (2005) New science-based endpoints to accelerate oncology drug development. Eur J Cancer 41:491-501
15. Pignatti F, Aronsson B, Vamvakas S, Wade G, Papadouli I, Papaluca M, Moulon I, Le Courtois P (2002) Clinical trials for registration in the European Union: the EMEA 5-year experience in oncology. Crit Rev Oncol Hematol 42:123-135
16. CPMP/602/00 Applications in the Centralised Procedures 1995 to July 1999-an analysis of outcomes. http://www.emea.europa.eu/pdfs/human/regaffair/ 060200en.pdf. Cited 7 Sept 2006
17. Ray WA, Stein CM (2006) Reform of drug regulation-beyond an independent drug-safety board. N Engl J Med 354:194-201
18. The European parliament and the Council of the European Union, regulation 726/2004. Official Journal of European Union L136/2:1-33
19. Tsang L (2005) Overhauling oversight-european drug legislation. Nat Biotechnol 23:1050-1053