Partial orphan cancer drugs: FDA approval, clinical benefit, trials, epidemiology, price, beneficiaries, and spending

被引:0
|
作者
Michaeli, D. T. [1 ]
Michaeli, C. T. [2 ]
机构
[1] Heidelberg Univ Hosp, Natl Ctr Tumor Dis, Dept Med Oncol, Heidelberg, Germany
[2] UMM Univ Klinikum Mannheim, Abteilung Personalisierte Onkol Schwerpunkt Lung, Mannheim, Germany
关键词
D O I
10.1016/j.annonc.2023.09.2650
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
1696MO
引用
收藏
页码:S927 / S927
页数:1
相关论文
共 50 条
  • [41] Participation of Black US Residents in Clinical Trials of 24 Cardiovascular Drugs Granted FDA Approval, 2006-2020
    Chen, Siliang
    Li, Jiarui
    JAMA NETWORK OPEN, 2021, 4 (03)
  • [42] Magnitude of clinical benefit of randomized controlled trials supporting US Food and Drug Administration approval of drugs for solid tumours
    Molto Valiente, C.
    Amir, E.
    Fernandez, A. Ocana
    Templeton, A.
    del Carpio Huerta, L.
    Del Paggio, J.
    Barnadas, A.
    Booth, C.
    Tibau, A.
    ANNALS OF ONCOLOGY, 2017, 28
  • [43] Clinical benefit of randomized controlled trials (RCT) supporting US Food and Drug Administration (FDA) conversion from accelerated to full approval
    Borrell Puy, M.
    Molto Valiente, C.
    Ocana Fernandez, A.
    Templeton, A.
    Seruga, B.
    Gich, I.
    Barnadas, A.
    Amir, E.
    Tibau, A.
    ANNALS OF ONCOLOGY, 2017, 28
  • [44] Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia
    Hwang, Thomas J.
    Kesselheim, Aaron S.
    Tibau, Ariadna
    Lee, ChangWon C.
    Vokinger, Kerstin N.
    JCO ONCOLOGY PRACTICE, 2022, 18 (09) : 676 - E1532
  • [45] Magnitude of clinical benefit in trials supporting US Food and Drug Administration (FDA) accelerated approval (AA) and European Medicines Agency (EMA) conditional marketing authorisation (CMA) and subsequent trials supporting conversion to full approval
    Borrell Puy, M.
    Molto Valiente, C.
    Vokinger, K.
    Hwang, T.
    Ocana Fernandez, A.
    Templeton, A. J.
    Seruga, B.
    Gich Saladich, I.
    Barnadas, A.
    Amir, E.
    Tibau, A.
    ANNALS OF ONCOLOGY, 2018, 29
  • [46] Estimated Medicare Spending on Cancer Drug Indications With a Confirmed Lack of Clinical Benefit After US Food and Drug Administration Accelerated Approval
    Shahzad, Mahnum
    Naci, Huseyin
    Wagner, Anita K.
    JAMA INTERNAL MEDICINE, 2021, 181 (12) : 1673 - 1675
  • [47] MARKET ACCESS FOR ANTI-CANCER DRUGS: IS THE DEMONSTRATION OF A CLINICAL BENEFIT ON SURVIVAL CORRELATED WITH PRICE LEVEL?
    Grange, L.
    Borget, I
    Duteil, E.
    VALUE IN HEALTH, 2023, 26 (12) : S380 - S380
  • [48] Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study
    Zou, Constance X.
    Becker, Jessica E.
    Phillips, Adam T.
    Garritano, James M.
    Krumholz, Harlan M.
    Miller, Jennifer E.
    Ross, Joseph S.
    TRIALS, 2018, 19
  • [49] Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study
    Constance X. Zou
    Jessica E. Becker
    Adam T. Phillips
    James M. Garritano
    Harlan M. Krumholz
    Jennifer E. Miller
    Joseph S. Ross
    Trials, 19
  • [50] Characteristics of pharmacogenomics/biomarker-guided clinical trials for regulatory approval of anti-cancer drugs in Japan
    Ishiguro, Akihiro
    Yagi, Satomi
    Uyama, Yoshiaki
    JOURNAL OF HUMAN GENETICS, 2013, 58 (06) : 313 - 316