BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

304 related articles for article (PubMed ID: 35921606)

  • 1. Overall Survival, Progression-Free Survival, and Tumor Response Benefit Supporting Initial US Food and Drug Administration Approval and Indication Extension of New Cancer Drugs, 2003-2021.
    Michaeli DT; Michaeli T
    J Clin Oncol; 2022 Dec; 40(35):4095-4106. PubMed ID: 35921606
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA.
    Michaeli DT; Mills M; Michaeli T; Miracolo A; Kanavos P
    Invest New Drugs; 2022 Aug; 40(4):798-809. PubMed ID: 35389145
    [TBL] [Abstract][Full Text] [Related]  

  • 3. 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]  

  • 4. Cancer Drug Prices in the United States: Efficacy, Innovation, Clinical Trial Evidence, and Epidemiology.
    Michaeli DT; Michaeli T
    Value Health; 2023 Nov; 26(11):1590-1600. PubMed ID: 37516196
    [TBL] [Abstract][Full Text] [Related]  

  • 5. A Survey of Survival Outcomes for Targeted Cancer Drugs Approved by the US Food and Drug Administration.
    He Q; Li Q; Lv F; Kaitin KI; Shao L
    Ther Innov Regul Sci; 2021 Jul; 55(4):676-684. PubMed ID: 33683659
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Breakthrough Therapy Cancer Drugs and Indications With FDA Approval: Development Time, Innovation, Trials, Clinical Benefit, Epidemiology, and Price.
    Michaeli DT; Michaeli T
    J Natl Compr Canc Netw; 2024 Apr; 22(4):. PubMed ID: 38648855
    [TBL] [Abstract][Full Text] [Related]  

  • 7. FDA approval, clinical trial evidence, efficacy, epidemiology, and price for non-orphan and ultra-rare, rare, and common orphan cancer drug indications: cross sectional analysis.
    Michaeli T; Jürges H; Michaeli DT
    BMJ; 2023 May; 381():e073242. PubMed ID: 37160306
    [TBL] [Abstract][Full Text] [Related]  

  • 8. 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]  

  • 9. Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019.
    Dhodapkar M; Zhang AD; Puthumana J; Downing NS; Shah ND; Ross JS
    JAMA Netw Open; 2021 Jun; 4(6):e2113224. PubMed ID: 34110392
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Estimation of Study Time Reduction Using Surrogate End Points Rather Than Overall Survival in Oncology Clinical Trials.
    Chen EY; Joshi SK; Tran A; Prasad V
    JAMA Intern Med; 2019 May; 179(5):642-647. PubMed ID: 30933235
    [TBL] [Abstract][Full Text] [Related]  

  • 11. The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020.
    Gloy V; Schmitt AM; Düblin P; Hirt J; Axfors C; Kuk H; Pereira TV; Locher C; Caquelin L; Walter-Claudi M; Lythgoe MP; Herbrand A; Kasenda B; Hemkens LG
    Int J Cancer; 2023 Jun; 152(12):2474-2484. PubMed ID: 36779785
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.
    Downing NS; Aminawung JA; Shah ND; Krumholz HM; Ross JS
    JAMA; 2014 Jan 22-29; 311(4):368-77. PubMed ID: 24449315
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Trends in endpoint use in pivotal trials and efficacy for US Food and Drug Administration-approved solid tumor therapies, 1995-2021.
    Alabaku O; Laffey TN; Suh K; Li M
    J Manag Care Spec Pharm; 2022 Nov; 28(11):1219-1223. PubMed ID: 36282934
    [No Abstract]   [Full Text] [Related]  

  • 14. Cancer Drug Approvals That Displaced Existing Standard-of-Care Therapies, 2016-2021.
    Benjamin DJ; Xu A; Lythgoe MP; Prasad V
    JAMA Netw Open; 2022 Mar; 5(3):e222265. PubMed ID: 35289858
    [TBL] [Abstract][Full Text] [Related]  

  • 15. Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.
    Hwang TJ; Franklin JM; Chen CT; Lauffenburger JC; Gyawali B; Kesselheim AS; Darrow JJ
    J Clin Oncol; 2018 Jun; 36(18):1805-1812. PubMed ID: 29688832
    [TBL] [Abstract][Full Text] [Related]  

  • 16. 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]  

  • 17. U.S. Food and Drug Administration anticancer drug approval trends from 2016 to 2018 for lung, colorectal, breast, and prostate cancer.
    Ribeiro TB; Ribeiro A; Rodrigues LO; Harada G; Nobre MRC
    Int J Technol Assess Health Care; 2020; 36(1):20-28. PubMed ID: 31775939
    [TBL] [Abstract][Full Text] [Related]  

  • 18. An empirical analysis of overall survival in drug approvals by the US FDA (2006-2023).
    Elbaz J; Haslam A; Prasad V
    Cancer Med; 2024 Apr; 13(8):e7190. PubMed ID: 38659418
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Characteristics and outcomes of new molecular oncology drug approvals, in combination or monotherapy.
    Ranganathan S; Haslam A; Tuia J; Prasad V
    J Cancer Policy; 2024 Mar; 39():100462. PubMed ID: 38061492
    [TBL] [Abstract][Full Text] [Related]  

  • 20. Feasibility of Randomized Controlled Trials for Cancer Drugs Approved by the Food and Drug Administration Based on Single-Arm Studies.
    Rittberg R; Czaykowski P; Niraula S
    JNCI Cancer Spectr; 2021 Aug; 5(4):. PubMed ID: 34409254
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 16.