BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

147 related articles for article (PubMed ID: 38648855)

  • 1. 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]  

  • 2. 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]  

  • 3. Clinical benefit, development, innovation, trials, epidemiology, and price for cancer drugs and indications with multiple special FDA designations.
    Michaeli DT; Michaeli T; Albers S; Michaeli JC
    J Natl Cancer Inst; 2024 Feb; 116(2):216-229. PubMed ID: 37824202
    [TBL] [Abstract][Full Text] [Related]  

  • 4. 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]  

  • 5. Partial Orphan Cancer Drugs: US Food and Drug Administration Approval, Clinical Benefit, Trials, Epidemiology, Price, Beneficiaries, and Spending.
    Michaeli T; Michaeli DT
    Value Health; 2024 Apr; 27(4):449-457. PubMed ID: 38244983
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration.
    Molto C; Hwang TJ; Borrell M; Andres M; Gich I; Barnadas A; Amir E; Kesselheim AS; Tibau A
    Cancer; 2020 Oct; 126(19):4390-4399. PubMed ID: 32697362
    [TBL] [Abstract][Full Text] [Related]  

  • 7. 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]  

  • 8. 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]  

  • 9. 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]  

  • 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. 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]  

  • 12. 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]  

  • 13. 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]  

  • 14. Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval.
    Liu ITT; Kesselheim AS; Cliff ERS
    JAMA; 2024 May; 331(17):1471-1479. PubMed ID: 38583175
    [TBL] [Abstract][Full Text] [Related]  

  • 15. 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]  

  • 16. Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy.
    Michaeli DT; Michaeli T; Albers S; Boch T; Michaeli JC
    Eur J Health Econ; 2023 Nov; ():. PubMed ID: 37962724
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Expedited Programs for Serious Conditions: An Update on Breakthrough Therapy Designation.
    Kwok M; Foster T; Steinberg M
    Clin Ther; 2015 Sep; 37(9):2104-20. PubMed ID: 26297571
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Impact of a Biomarker-Based Strategy on Oncology Drug Development: A Meta-analysis of Clinical Trials Leading to FDA Approval.
    Jardim DL; Schwaederle M; Wei C; Lee JJ; Hong DS; Eggermont AM; Schilsky RL; Mendelsohn J; Lazar V; Kurzrock R
    J Natl Cancer Inst; 2015 Nov; 107(11):. PubMed ID: 26378224
    [TBL] [Abstract][Full Text] [Related]  

  • 19. 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]  

  • 20. 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]  

    [Next]    [New Search]
    of 8.