메뉴 건너뛰기




Volumn 32, Issue 4, 2014, Pages 323-330

A survey of breakthrough therapy designations

Author keywords

[No Author keywords available]

Indexed keywords

DRUG THERAPY;

EID: 84900859536     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt.2864     Document Type: Article
Times cited : (37)

References (43)
  • 1
    • 84887412695 scopus 로고    scopus 로고
    • Expediting drug development-The FDAs new breakthrough therapy designation
    • Sherman, R.E., Li, J., Shapley, S., Robb, M. & Woodcock, J. Expediting drug development-The FDAs new breakthrough therapy designation. N. Engl. J. Med. 369, 1877-1880 (2013).
    • (2013) N. Engl. J. Med , vol.369 , pp. 1877-1880
    • Sherman, R.E.1    Li, J.2    Shapley, S.3    Robb, M.4    Woodcock, J.5
  • 2
    • 84900864396 scopus 로고    scopus 로고
    • Drugs with breakthrough status charm investors
    • Senior, M. Drugs with breakthrough status charm investors. Nat. Biotechnol. 31, 945-947 (2013).
    • (2013) Nat. Biotechnol , vol.31 , pp. 945-947
    • Senior, M.1
  • 4
    • 84892170718 scopus 로고    scopus 로고
    • Whats fueling the biotech engine-2012 to 2013
    • Aggarwal, R.S. Whats fueling the biotech engine-2012 to 2013. Nat. Biotechnol. 32, 32-39 (2014).
    • (2014) Nat. Biotechnol , vol.32 , pp. 32-39
    • Aggarwal, R.S.1
  • 5
    • 84870949388 scopus 로고    scopus 로고
    • Whats fueling the biotech engine-2011 to 2012
    • Aggarwal, S.R. Whats fueling the biotech engine-2011 to 2012. Nat. Biotechnol. 30, 1191- 1197 (2012).
    • (2012) Nat. Biotechnol , vol.30 , pp. 1191-1197
    • Aggarwal, S.R.1
  • 6
    • 77953143235 scopus 로고    scopus 로고
    • Targeted cancer therapies
    • Aggarwal, S. Targeted cancer therapies. Nat. Rev. Drug Discov. 9, 427-428 (2010).
    • (2010) Nat. Rev. Drug Discov , vol.9 , pp. 427-428
    • Aggarwal, S.1
  • 7
    • 77950331000 scopus 로고    scopus 로고
    • CD20 as a target for therapeutic type i and II monoclonal antibodies
    • Beers, S.A., Chan, C.H., French, R.R., Cragg, M.S. & Glennie, M.J. CD20 as a target for therapeutic type I and II monoclonal antibodies. Semin. Hematol. 47, 107-114 (2010).
    • (2010) Semin. Hematol , vol.47 , pp. 107-114
    • Beers, S.A.1    Chan, C.H.2    French, R.R.3    Cragg, M.S.4    Glennie, M.J.5
  • 8
    • 84856080627 scopus 로고    scopus 로고
    • Cost-effectiveness of adding rituximab to fludarabine and cyclophosphamide for the treatment of previously untreated chronic lymphocytic leukemia
    • Hornberger, J. et al. Cost-effectiveness of adding rituximab to fludarabine and cyclophosphamide for the treatment of previously untreated chronic lymphocytic leukemia. Leuk. Lymphoma 53, 225-234 (2012).
    • (2012) Leuk. Lymphoma , vol.53 , pp. 225-234
    • Hornberger, J.1
  • 9
    • 84875032090 scopus 로고    scopus 로고
    • Novel Brutons tyrosine kinase inhibitors currently in development
    • DCruz, O.J. & Uckun, F.M. Novel Brutons tyrosine kinase inhibitors currently in development. Onco Targets Ther. 6, 161-176 (2013).
    • (2013) Onco Targets Ther , vol.6 , pp. 161-176
    • Dcruz, O.J.1    Uckun, F.M.2
  • 10
    • 84900845925 scopus 로고    scopus 로고
    • Imbruvica drug to treat blood cancer, gains FDA approval
    • 13 November 2013
    • Pollack, A. Imbruvica, drug to treat blood cancer, gains FDA approval. The New York Times http://www.nytimes. com/2013/11/14/business/drug-to-treat- blood-cancergains- fda-approval.html?-r=0 (13 November 2013).
    • The New York Times
    • Pollack, A.1
  • 12
    • 84900861612 scopus 로고    scopus 로고
    • Sovaldi approved to treat chronic hepatitis C
    • 9 December 2013
    • Lowery, M. Sovaldi approved to treat chronic hepatitis C. Drug Topics http://drugtopics.modernmedicine. com/drug-topics/news/sovaldi-approved-treat- chronichepatitis- c?page=full (9 December 2013).
    • Drug Topics
    • Lowery, M.1
  • 13
    • 84900874669 scopus 로고    scopus 로고
    • Ofatumumab + chlorambucil versus chlorambucil alone in patients with untreated chronic lymphocytic leukemia: Results of the phase 3 study complement 1
    • 9 December 2013
    • Hillman, P. et al. Ofatumumab + chlorambucil versus chlorambucil alone in patients with untreated chronic lymphocytic leukemia: results of the phase 3 study complement 1. Oral presentation, 55th Annual Meeting of the American Society of Hematology, New Orleans (9 December 2013).
    • Oral Presentation, 55th Annual Meeting of the American Society of Hematology, New Orleans
    • Hillman, P.1
  • 15
    • 84879834815 scopus 로고    scopus 로고
    • Randomized phase II, double-blind, placebo-controlled study of exemestane with or without entinostat in postmenopausal women with locally recurrent or metastatic estrogen receptor-positive breast cancer progressing on treatment with a nonsteroidal aromatase inhibitor
    • Yardley, D.A. et al. Randomized phase II, double-blind, placebo-controlled study of exemestane with or without entinostat in postmenopausal women with locally recurrent or metastatic estrogen receptor-positive breast cancer progressing on treatment with a nonsteroidal aromatase inhibitor. J. Clin. Oncol. 31, 2128-2135 (2013).
    • (2013) J. Clin. Oncol , vol.31 , pp. 2128-2135
    • Yardley, D.A.1
  • 16
    • 84884993118 scopus 로고    scopus 로고
    • Clinical activity of the ALK inhibitor LDK378 in advanced
    • Abstract
    • Shaw, A. et al. Clinical activity of the ALK inhibitor LDK378 in advanced, ALK-positive NSCLC. J. Clin. Oncol. 31, Abstract 8010 (2013).
    • (2013) ALK-positive NSCLC. J. Clin. Oncol. , vol.31 , pp. 8010
    • Shaw, A.1
  • 17
    • 84900839946 scopus 로고    scopus 로고
    • Phase I/II study of volasertib (BI 6727) an intravenous Polo-like kinase (Plk) inhibitor, in patients with acute myeloid leukemia (AML): Results from the randomized phase II part for volasertib in combination with low-dose cytarabine (LDAC) versus LDAC monotherapy in patients with previously untreated AML ineligible for intensive treatment
    • 8-11 December 2012
    • Dhner, H. Phase I/II study of volasertib (BI 6727), an intravenous Polo-like kinase (Plk) inhibitor, in patients with acute myeloid leukemia (AML): results from the randomized phase II part for volasertib in combination with low-dose cytarabine (LDAC) versus LDAC monotherapy in patients with previously untreated AML ineligible for intensive treatment. Oral presentation at ASH Annual Meeting and Exposition, New Orleans. (8-11 December 2012).
    • Oral Presentation at ASH Annual Meeting and Exposition, New Orleans
    • Dhner, H.1
  • 18
    • 84900865226 scopus 로고    scopus 로고
    • 9 February 2012
    • Eisai, Inc. FDA ODAC Briefing Document. Dacogen http://www.fda.gov/ downloads/AdvisoryCommittees/ C o m m i t t e e s M e e t i n g M a t e r i a l s / D r u g s / OncologicDrugsAdvisoryCommittee/UCM290512.pdf (9 February 2012).
    • Eisai, Inc. FDA ODAC Briefing Document. Dacogen
  • 19
    • 84866912683 scopus 로고    scopus 로고
    • Ipilimumab (Yervoy) prolongs survival in advanced melanoma
    • Fellner, C. Ipilimumab (Yervoy) prolongs survival in advanced melanoma. Pharm. Ther. 37, 503-511 (2012).
    • (2012) Pharm. Ther , vol.37 , pp. 503-511
    • Fellner, C.1
  • 22
    • 84863393533 scopus 로고    scopus 로고
    • Enzyme-replacement therapy in lifethreatening hypophosphatasia
    • Whyte, M.P. et al. Enzyme-replacement therapy in lifethreatening hypophosphatasia. N. Engl. J. Med. 366, 904-913 (2012).
    • (2012) N. Engl. J. Med , vol.366 , pp. 904-913
    • Whyte, M.P.1
  • 24
    • 79955158683 scopus 로고    scopus 로고
    • Systemic administration of PRO051 in Duchennes Muscular Dystrophy
    • Goemans, N.M. et al. Systemic administration of PRO051 in Duchennes Muscular Dystrophy. N. Engl. J. Med. 364, 1513-1522 (2011).
    • (2011) N. Engl. J. Med , vol.364 , pp. 1513-1522
    • Goemans, N.M.1
  • 27
    • 77950611229 scopus 로고    scopus 로고
    • Institute of Medicine recommendations for the prevention and control of hepatitis B and C
    • Mitchell, A.E., Colvin, H.M. & Palmer Beasley, R. Institute of Medicine recommendations for the prevention and control of hepatitis B and C. Hepatology 51, 729-733 (2010).
    • (2010) Hepatology , vol.51 , pp. 729-733
    • Mitchell, A.E.1    Colvin, H.M.2    Palmer Beasley, R.3
  • 28
    • 65449136656 scopus 로고    scopus 로고
    • Diagnosis, management, and treatment of hepatitis C: An update
    • Ghany, M.G., Strader, D.B., Thomas, D.L. & Seeff, L.B. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 49, 1335-1374 (2009).
    • (2009) Hepatology , vol.49 , pp. 1335-1374
    • Ghany, M.G.1    Strader, D.B.2    Thomas, D.L.3    Seeff, L.B.4
  • 29
    • 84877782905 scopus 로고    scopus 로고
    • Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies
    • Chen, J. et al. Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies. Gastroenterology 144, 1450-1455 (2013).
    • (2013) Gastroenterology , vol.144 , pp. 1450-1455
    • Chen, J.1
  • 30
    • 84892761609 scopus 로고    scopus 로고
    • Efficacy of an interferon and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection
    • Everson, G.T. et al. Efficacy of an interferon and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology 146, 420-429 (2014).
    • (2014) Gastroenterology , vol.146 , pp. 420-429
    • Everson, G.T.1
  • 31
    • 84857395452 scopus 로고    scopus 로고
    • Dual therapy with the nonstructural protein 5A inhibitor, daclatasvir, and the nonstructural protein 3 protease inhibitor, asunaprevir, in hepatitis C virus genotype 1b-infected null responders
    • Chayama, K. et al. Dual therapy with the nonstructural protein 5A inhibitor, daclatasvir, and the nonstructural protein 3 protease inhibitor, asunaprevir, in hepatitis C virus genotype 1b-infected null responders. Hepatology 55, 742-748 (2012).
    • (2012) Hepatology , vol.55 , pp. 742-748
    • Chayama, K.1
  • 32
    • 84892591928 scopus 로고    scopus 로고
    • Phase 2b trial of interferon-free therapy for hepatitis c virus genotype 1
    • Kowdley, K.V. et al. Phase 2b trial of interferon-free therapy for hepatitis c virus genotype 1. N. Engl. J. Med. 370, 222-232 (2014).
    • (2014) N. Engl. J. Med , vol.370 , pp. 222-232
    • Kowdley, K.V.1
  • 33
    • 84894621765 scopus 로고    scopus 로고
    • Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatmentnaive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): An open-label, randomised, phase 2 trial
    • Lawitz, E. et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatmentnaive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet 383, 515-523 (2014).
    • (2014) Lancet , vol.383 , pp. 515-523
    • Lawitz, E.1
  • 34
    • 84900857355 scopus 로고    scopus 로고
    • High efficacy and safety of the all-oral combination regimen MK-5172/MK-8742 +/RBV for 12 weeks in HCV genotype 1 infected patients: The C-WORTHY study
    • abstract1-5 November 2013
    • Lawitz, E. et al. High efficacy and safety of the all-oral combination regimen, MK-5172/MK-8742 +/RBV for 12 weeks in HCV genotype 1 infected patients: the C-WORTHY study. 64th Annual Meeting of the American Association for the Study of Liver diseases, Washington, DC; abstract 76 36 (1-5 November 2013).
    • 64th Annual Meeting of the American Association for the Study of Liver Diseases Washington DC , vol.76 , pp. 36
    • Lawitz, E.1
  • 37
    • 84900868180 scopus 로고    scopus 로고
    • And a monoclonal antibody treatment helps with muscle volume in sIBM
    • Collins, T.R., And a monoclonal antibody treatment helps with muscle volume in sIBM. Neurology Today 13, 34-35 (2013).
    • (2013) Neurology Today , vol.13 , pp. 34-35
    • Collins, T.R.1
  • 40
    • 84897513351 scopus 로고    scopus 로고
    • Eltrombopag restores tri-lineage hematopoiesis in refractory severe aplastic anemia which can be sustained on discontinuation of drug
    • doi:10.1182/blood-2013-10-534743 (17 December 2013)
    • Desmond, R. et al. Eltrombopag restores tri-lineage hematopoiesis in refractory severe aplastic anemia which can be sustained on discontinuation of drug. Blood doi:10.1182/blood-2013-10-534743 (17 December 2013).
    • Blood
    • Desmond, R.1
  • 41
    • 84898544373 scopus 로고    scopus 로고
    • Serelaxin in acute heart failure patients with preserved left ventricular ejection fraction: Results from the RELAX-AHF trial
    • doi:10.1093/eurheartj/eht497 6 December 2013
    • Filippatos, G. et al. Serelaxin in acute heart failure patients with preserved left ventricular ejection fraction: results from the RELAX-AHF trial. Eur. Heart J. doi:10.1093/eurheartj/eht497 (6 December 2013).
    • Eur. Heart J
    • Filippatos, G.1
  • 42
    • 84900874659 scopus 로고    scopus 로고
    • Refusal of the marketing authorization for Readanz
    • 21 February 2014
    • European Medicines Agency. Refusal of the marketing authorization for Readanz http://www.ema.europa.eu/docs/en-GB/document-library/Summary-of-opinion- Initial-authorisation/human/002817/WC500160088. pdf (21 February 2014).
    • European Medicines Agency
  • 43
    • 84896489887 scopus 로고    scopus 로고
    • Tafenoquine plus chloroquine for the treatment and relapse prevention of Plasmodium vivax malaria (DETECTIVE): A multicentre doubleblind randomised phase 2b dose-selection study
    • doi:10.1016/S0140-6736(13)62568-4 (19 December 2013)
    • Llanos-Cuentas, A. et al. Tafenoquine plus chloroquine for the treatment and relapse prevention of Plasmodium vivax malaria (DETECTIVE): a multicentre, doubleblind, randomised, phase 2b dose-selection study. Lancet doi:10.1016/S0140-6736(13)62568-4 (19 December 2013).
    • Lancet
    • Llanos-Cuentas, A.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.