BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

154 related articles for article (PubMed ID: 38175382)

  • 1. Characteristics of Anticancer Drugs Approved Under the Accelerated Approval Program in the US: Success or Failure in Converting to Regular Approval.
    Oda Y; Narukawa M
    Ther Innov Regul Sci; 2024 Mar; 58(2):387-394. PubMed ID: 38175382
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
    Salcher-Konrad M; Naci H; Davis C
    Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
    [TBL] [Abstract][Full Text] [Related]  

  • 3. US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018.
    Omae K; Onishi A; Sahker E; Furukawa TA
    JAMA Netw Open; 2022 Sep; 5(9):e2230973. PubMed ID: 36083581
    [TBL] [Abstract][Full Text] [Related]  

  • 4. A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.
    Beaver JA; Howie LJ; Pelosof L; Kim T; Liu J; Goldberg KB; Sridhara R; Blumenthal GM; Farrell AT; Keegan P; Pazdur R; Kluetz PG
    JAMA Oncol; 2018 Jun; 4(6):849-856. PubMed ID: 29494733
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?
    Richey EA; Lyons EA; Nebeker JR; Shankaran V; McKoy JM; Luu TH; Nonzee N; Trifilio S; Sartor O; Benson AB; Carson KR; Edwards BJ; Gilchrist-Scott D; Kuzel TM; Raisch DW; Tallman MS; West DP; Hirschfeld S; Grillo-Lopez AJ; Bennett CL
    J Clin Oncol; 2009 Sep; 27(26):4398-405. PubMed ID: 19636013
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Increasing FDA-accelerated approval of single-arm trials in oncology (1992 to 2020).
    Ribeiro TB; Bennett CL; Colunga-Lozano LE; Araujo APV; Hozo I; Djulbegovic B
    J Clin Epidemiol; 2023 Jul; 159():151-158. PubMed ID: 37037322
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan.
    Ito A; Narukawa M
    Ther Innov Regul Sci; 2024 Jan; 58(1):136-142. PubMed ID: 37787890
    [TBL] [Abstract][Full Text] [Related]  

  • 8. Response rate of anticancer drugs approved by the Food and Drug Administration based on a single-arm trial.
    Oda Y; Narukawa M
    BMC Cancer; 2022 Mar; 22(1):277. PubMed ID: 35291959
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study.
    Gyawali B; Rome BN; Kesselheim AS
    BMJ; 2021 Sep; 374():n1959. PubMed ID: 34497044
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Factors Related to Conversion from Accelerated to Full Approval for Drugs Approved in the United States Between 2000 and 2016.
    Irisawa K; Kaneko M; Narukawa M
    Ther Innov Regul Sci; 2021 Jan; 55(1):82-89. PubMed ID: 32602027
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017.
    Skydel JJ; Egilman AC; Wallach JD; Ramachandran R; Gupta R; Ross JS
    JAMA Health Forum; 2022 May; 3(5):e221158. PubMed ID: 35977252
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Accelerated approval of oncology products: the food and drug administration experience.
    Johnson JR; Ning YM; Farrell A; Justice R; Keegan P; Pazdur R
    J Natl Cancer Inst; 2011 Apr; 103(8):636-44. PubMed ID: 21422403
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.
    Ladanie A; Schmitt AM; Speich B; Naudet F; Agarwal A; Pereira TV; Sclafani F; Herbrand AK; Briel M; Martin-Liberal J; Schmid T; Ewald H; Ioannidis JPA; Bucher HC; Kasenda B; Hemkens LG
    JAMA Netw Open; 2020 Nov; 3(11):e2024406. PubMed ID: 33170262
    [TBL] [Abstract][Full Text] [Related]  

  • 14. An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate.
    Chen EY; Raghunathan V; Prasad V
    JAMA Intern Med; 2019 Jul; 179(7):915-921. PubMed ID: 31135822
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.
    Naci H; Smalley KR; Kesselheim AS
    JAMA; 2017 Aug; 318(7):626-636. PubMed ID: 28810023
    [TBL] [Abstract][Full Text] [Related]  

  • 16. National Comprehensive Cancer Network Guideline Recommendations of Cancer Drugs With Accelerated Approval.
    Cliff ERS; Rome RS; Kesselheim AS; Rome BN
    JAMA Netw Open; 2023 Nov; 6(11):e2343285. PubMed ID: 37962889
    [TBL] [Abstract][Full Text] [Related]  

  • 17. FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1.
    Sul J; Blumenthal GM; Jiang X; He K; Keegan P; Pazdur R
    Oncologist; 2016 May; 21(5):643-50. PubMed ID: 27026676
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration.
    Hilal T; Sonbol MB; Prasad V
    JAMA Oncol; 2019 Jun; 5(6):887-892. PubMed ID: 31046071
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.
    Gyawali B; Hey SP; Kesselheim AS
    JAMA Intern Med; 2019 Jul; 179(7):906-913. PubMed ID: 31135808
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Estimating the Potential Benefits of Confirmatory Trials for Drugs with Accelerated Approval: A Comprehensive Value of Information Framework.
    Jiao B
    Pharmacoeconomics; 2023 Dec; 41(12):1617-1627. PubMed ID: 37490206
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.