-
1
-
-
84655170271
-
The European Medicines Agency review of ipilimumab (Yervoy) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use
-
PMID:22030452
-
Hanaizi Z, van Zwieten-Boot B, Calvo G, Lopez AS, van Dartel M, Camarero J, et al. The European Medicines Agency review of ipilimumab (Yervoy) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy: summary of the scientific assessment of the Committee for Medicinal Products for Human Use. Eur J Cancer 2012; 48:237-42; PMID:22030452; http://dx.doi.org/10.1016/j.ejca.2011.09.018.
-
(2012)
Eur J Cancer
, vol.48
, pp. 237-242
-
-
Hanaizi, Z.1
Van Zwieten-Boot, B.2
Calvo, G.3
Lopez, A.S.4
Van Dartel, M.5
Camarero, J.6
-
2
-
-
67651049056
-
Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): Final analysis of a double-blind, randomised study in young women
-
HPV PATRICIA Study Group PMID:19586656
-
Paavonen J, Naud P, Salmerón J, Wheeler CM, Chow SN, Apter D, et al.; HPV PATRICIA Study Group. Efficacy of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by oncogenic HPV types (PATRICIA): final analysis of a double-blind, randomised study in young women. Lancet 2009; 374:301-14; PMID:19586656; http://dx.doi.org/10.1016/S0140-6736(09)61248-4.
-
(2009)
Lancet
, vol.374
, pp. 301-314
-
-
Paavonen, J.1
Naud, P.2
Salmerón, J.3
Wheeler, C.M.4
Chow, S.N.5
Apter, D.6
-
3
-
-
77953245367
-
Landmark approval for Dendreon's cancer vaccine
-
PMID:20531312
-
DeFrancesco L. Landmark approval for Dendreon's cancer vaccine. Nat Biotechnol 2010; 28:531-2; PMID:20531312; http://dx.doi.org/10.1038/nbt0610-531.
-
(2010)
Nat Biotechnol
, vol.28
, pp. 531-532
-
-
DeFrancesco, L.1
-
4
-
-
84867005576
-
Vaccines for human use
-
7th edition
-
Vaccines for human use. European Pharmacopoeia 2012, 7th edition.
-
(2012)
European Pharmacopoeia
-
-
-
5
-
-
84878265635
-
-
accessed May 31, 2012
-
www.clinicaltrials.gov (accessed May 31, 2012)
-
-
-
-
6
-
-
84878265510
-
-
accessed May 31, 2012
-
www.clinicaltrialsregister.eu/index.html (accessed May 31, 2012)
-
-
-
-
7
-
-
34447136106
-
Cancer vaccines: Moving beyond current paradigms
-
PMID:17606707
-
Schlom J, Arlen PM, Gulley JL. Cancer vaccines: moving beyond current paradigms. Clin Cancer Res 2007; 13:3776-82; PMID:17606707; http://dx.doi.org/ 10.1158/1078-0432.CCR-07-0588.
-
(2007)
Clin Cancer Res
, vol.13
, pp. 3776-3782
-
-
Schlom, J.1
Arlen, P.M.2
Gulley, J.L.3
-
8
-
-
77957273591
-
Improved endpoints for cancer immunotherapy trials
-
PMID:20826737
-
Hoos A, Eggermont AMM, Janetzki S, Hodi FS, Ibrahim R, Anderson A, et al. Improved endpoints for cancer immunotherapy trials. J Natl Cancer Inst 2010; 102:1388-97; PMID:20826737; http://dx.doi.org/10.1093/jnci/djq310.
-
(2010)
J Natl Cancer Inst
, vol.102
, pp. 1388-1397
-
-
Hoos, A.1
Eggermont, A.M.M.2
Janetzki, S.3
Hodi, F.S.4
Ibrahim, R.5
Anderson, A.6
-
9
-
-
23444460612
-
Regulation (EC) no 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
-
Regulation (EC) no 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Off J Eur Union 2004; L136:1-32.
-
(2004)
Off J Eur Union
, vol.L136
, pp. 1-32
-
-
-
10
-
-
34547725155
-
Methodological recommendations of the regulatory agencies
-
Barc PMID:16464431
-
Torres F, Calvo G, Pontes C. Methodological recommendations of the regulatory agencies. Med Clin (Barc) 2005; 125(Suppl 1):72-6; PMID:16464431; http://dx.doi.org/10.1016/S0025-7753(05)72213-2.
-
(2005)
Med Clin
, vol.125
, Issue.SUPPL. 1
, pp. 72-76
-
-
Torres, F.1
Calvo, G.2
Pontes, C.3
-
11
-
-
84878264974
-
-
accessed June 8, 2001
-
www.ema.europa.eu (accessed June 8, 2001)
-
-
-
-
12
-
-
84878266127
-
-
accessed June 8, 2001
-
www.edqm.eu (accessed June 8, 2001)
-
-
-
-
13
-
-
84878265974
-
-
accessed June 4, 2012
-
www.ema.europa.eu/ema/index.jsp?curl=pages/medicines /human/medicines /001072/wapp/Initial-authorisation/human-wapp-000003.jsp&mid= WC0b01ac058001d128 (accessed June 4, 2012)
-
-
-
-
14
-
-
59349103735
-
Recent advances in cancer vaccines: An overview
-
PMID:19015149
-
Itoh K, Yamada A, Mine T, Noguchi M. Recent advances in cancer vaccines: an overview. Jpn J Clin Oncol 2009; 39:73-80; PMID:19015149; http://dx.doi.org/10.1093/jjco/hyn132.
-
(2009)
Jpn J Clin Oncol
, vol.39
, pp. 73-80
-
-
Itoh, K.1
Yamada, A.2
Mine, T.3
Noguchi, M.4
-
15
-
-
84878265730
-
-
accessed June 4, 2012
-
http://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ ApprovedProducts/ucm213554.htm (accessed June 4, 2012)
-
-
-
-
16
-
-
84878265475
-
-
accessed June 5, 2012
-
April 29, 2010 Approval Letter - Provenge. http://www.fda.gov/ BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm210215. htm (accessed June 5, 2012)
-
April 29, 2010 Approval Letter - Provenge
-
-
-
17
-
-
77955066199
-
Sipuleucel-T immunotherapy for castration-resistant prostate cancer
-
IMPACT Study Investigators PMID:20818862
-
Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, et al.; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010; 363:411-22; PMID:20818862; http://dx.doi.org/10.1056/NEJMoa1001294.
-
(2010)
N Engl J Med
, vol.363
, pp. 411-422
-
-
Kantoff, P.W.1
Higano, C.S.2
Shore, N.D.3
Berger, E.R.4
Small, E.J.5
Penson, D.F.6
-
18
-
-
46749085802
-
An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: A multicentre, open-label, randomised phase III trial
-
C-100-12 RCC Study Group. PMID:18602688
-
Wood C, Srivastava P, Bukowski R, Lacombe L, Gorelov AI, Gorelov S, et al.; C-100-12 RCC Study Group. An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: a multicentre, open-label, randomised phase III trial. Lancet 2008; 372:145-54; PMID:18602688; http://dx.doi.org/10.1016/S0140-6736(08)60697-2.
-
(2008)
Lancet
, vol.372
, pp. 145-154
-
-
Wood, C.1
Srivastava, P.2
Bukowski, R.3
Lacombe, L.4
Gorelov, A.I.5
Gorelov, S.6
-
19
-
-
54149097564
-
A vaccine for renal cancer
-
PMID:18970972
-
Wood C. A vaccine for renal cancer. Lancet 2008; 372:1460-1; PMID:18970972; http://dx.doi.org/10.1016/S0140-6736(08)61615-3.
-
(2008)
Lancet
, vol.372
, pp. 1460-1461
-
-
Wood, C.1
-
20
-
-
77958499413
-
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13
-
November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004.
-
Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. Off J Eur Union 2007; 324:121-37.
-
(2007)
Off J Eur Union
, vol.324
, pp. 121-137
-
-
-
21
-
-
38049026406
-
The regulator disapproves
-
PMID:18182998
-
The regulator disapproves. Nat Biotechnol 2008; 26:1; PMID:18182998; http://dx.doi.org/10.1038/nbt0108-1.
-
(2008)
Nat Biotechnol
, vol.26
, pp. 1
-
-
-
22
-
-
77955080349
-
New therapies for castration-resistant prostate cancer
-
editorial. PMID:20818868
-
Longo DL. New therapies for castration-resistant prostate cancer. [editorial]. N Engl J Med 2010; 363:479-81; PMID:20818868; http://dx.doi.org/10. 1056/NEJMe1006300.
-
(2010)
N Engl J Med
, vol.363
, pp. 479-481
-
-
Longo, D.L.1
-
23
-
-
84857397717
-
Interdisciplinary critique of sipuleucel-T as immunotherapy in castration-resistant prostate cancer
-
PMID:22232132
-
Huber ML, Haynes L, Parker C, Iversen P. Interdisciplinary critique of sipuleucel-T as immunotherapy in castration-resistant prostate cancer. J Natl Cancer Inst 2012; 104:273-9; PMID:22232132; http://dx.doi.org/10.1093/jnci/ djr514.
-
(2012)
J Natl Cancer Inst
, vol.104
, pp. 273-279
-
-
Huber, M.L.1
Haynes, L.2
Parker, C.3
Iversen, P.4
-
25
-
-
4744366279
-
Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer
-
TAX 327 Investigators PMID:15470213
-
Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, et al.; TAX 327 Investigators. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med 2004; 351:1502-12; PMID:15470213; http://dx.doi.org/10.1056/NEJMoa040720.
-
(2004)
N Engl J Med
, vol.351
, pp. 1502-1512
-
-
Tannock, I.F.1
De Wit, R.2
Berry, W.R.3
Horti, J.4
Pluzanska, A.5
Chi, K.N.6
-
26
-
-
79952253824
-
EAU guidelines on prostate cancer. Part II: Treatment of advanced, relapsing, and castration-resistant prostate cancer
-
PMID:21315502
-
Mottet N, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, et al. EAU guidelines on prostate cancer. Part II: Treatment of advanced, relapsing, and castration-resistant prostate cancer. Eur Urol 2011; 59:572-83; PMID:21315502; http://dx.doi.org/10.1016/j.eururo.2011.01.025.
-
(2011)
Eur Urol
, vol.59
, pp. 572-583
-
-
Mottet, N.1
Bellmunt, J.2
Bolla, M.3
Joniau, S.4
Mason, M.5
Matveev, V.6
-
27
-
-
76949104143
-
Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency
-
PMID:19936724
-
Regnstrom J, Koenig F, Aronsson B, Reimer T, Svendsen K, Tsigkos S, et al. Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency. Eur J Clin Pharmacol 2010; 66:39-48; PMID:19936724; http://dx.doi.org/10.1007/s00228-009- 0756-y.
-
(2010)
Eur J Clin Pharmacol
, vol.66
, pp. 39-48
-
-
Regnstrom, J.1
Koenig, F.2
Aronsson, B.3
Reimer, T.4
Svendsen, K.5
Tsigkos, S.6
|