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Volumn 19, Issue 16, 2013, Pages 4297-4304

Developing standards for breakthrough therapy designation in oncology

Author keywords

[No Author keywords available]

Indexed keywords

ANAPLASTIC LYMPHOMA KINASE; BRENTUXIMAB VEDOTIN; CRIZOTINIB; IBRUTINIB; IVACAFTOR; PALBOCICLIB; VEMURAFENIB; VISMODEGIB;

EID: 84882953749     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-13-0523     Document Type: Article
Times cited : (25)

References (9)
  • 1
    • 79953193825 scopus 로고    scopus 로고
    • Early accelerated approval for highly targeted cancer drugs
    • Chabner BA. Early accelerated approval for highly targeted cancer drugs. N Engl J Med 2011;364:1087-9.
    • (2011) N Engl J Med , vol.364 , pp. 1087-1089
    • Chabner, B.A.1
  • 2
    • 84859377987 scopus 로고    scopus 로고
    • Role of randomized phase III trials in an era of effective targeted therapies
    • Sharma MR, Schilsky RL. Role of randomized phase III trials in an era of effective targeted therapies. Nat Rev Clin Oncol 2012;9:208-14.
    • (2012) Nat Rev Clin Oncol , vol.9 , pp. 208-214
    • Sharma, M.R.1    Schilsky, R.L.2
  • 4
    • 79960238308 scopus 로고    scopus 로고
    • Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe
    • Roberts SA, Allen JD, Sigal EV. Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe. Health Aff 2011;30:1375-81.
    • (2011) Health Aff , vol.30 , pp. 1375-1381
    • Roberts, S.A.1    Allen, J.D.2    Sigal, E.V.3
  • 5
    • 33846995628 scopus 로고    scopus 로고
    • Economics of new oncology drug development
    • DiMasi JA, Grabowski HG. Economics of new oncology drug development. J Clin Oncol 2007;25:209-16.
    • (2007) J Clin Oncol , vol.25 , pp. 209-216
    • Dimasi, J.A.1    Grabowski, H.G.2
  • 9
    • 84856312648 scopus 로고    scopus 로고
    • FDA Cited: Apr. 15, 2013]
    • FDA. General Principles: EMEA-FDA Parallel Scientific Advice 2009. [Cited: Apr. 15, 2013]. Available from: http://www.fda. gov/ InternationalPrograms/FDABeyondOurBordersForeignOffices/EuropeanUnion/ EuropeanUnion/EuropeanCommission/ucm114345. htm.
    • (2009) General Principles: EMEA-FDA Parallel Scientific Advice


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.