Accelerated Approval of Cancer Drugs-Righting the Ship of the US Food and Drug Administration

被引：15
作者：
DiMagno, Sarah S. P. [1 ]
Glickman, Aaron [1 ]
Emanuel, Ezekiel J. [1 ,2 ]
机构：
[1] Univ Penn, Perelman Sch Med, Dept Med Eth & Hlth Policy, Philadelphia, PA 19104 USA
[2] Univ Penn, Wharton Sch, Dept Hlth Care Management, Philadelphia, PA 19104 USA
来源：
JAMA INTERNAL MEDICINE | 2019年 / 179卷 / 07期
关键词：
SURROGATE END-POINTS; ONCOLOGY; ASSOCIATION; SURVIVAL; STRENGTH;
D O I：
10.1001/jamainternmed.2019.0584
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
引用
收藏
页码：922 / 923
页数：2
相关论文
共 8 条
[1]   A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics A Review [J].
Beaver, Julia A. ;
Howie, Lynn J. ;
Pelosof, Lorraine ;
Kim, Tamy ;
Liu, Jinzhong ;
Goldberg, Kirsten B. ;
Sridhara, Rajeshwari ;
Blumenthal, Gideon M. ;
Farrell, Ann T. ;
Keegan, Patricia ;
Pazdur, Richard ;
Kluetz, Paul G. .
JAMA ONCOLOGY, 2018, 4 (06) :849-856
[2]   Oncology Drug Approvals: Evaluating Endpoints and Evidence in an Era of Breakthrough Therapies [J].
Blumenthal, Gideon M. ;
Kluetz, Paul G. ;
Schneider, Julie ;
Goldberg, Kirsten B. ;
McKee, Amy E. ;
Pazdur, Richard .
ONCOLOGIST, 2017, 22 (07) :762-767
[3]   An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate [J].
Chen, Emerson Y. ;
Raghunathan, Vikram ;
Prasad, Vinay .
JAMA INTERNAL MEDICINE, 2019, 179 (07) :915-921
[4]   Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. [J].
Druker, BJ ;
Talpaz, M ;
Resta, DJ ;
Peng, B ;
Buchdunger, E ;
Ford, JM ;
Lydon, NB ;
Kantarjian, H ;
Capdeville, R ;
Ohno-Jones, S ;
Sawyers, CL .
NEW ENGLAND JOURNAL OF MEDICINE, 2001, 344 (14) :1031-1037
[5]   Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval [J].
Gyawali, Bishal ;
Hey, Spencer Phillips ;
Kesselheim, Aaron S. .
JAMA INTERNAL MEDICINE, 2019, 179 (07) :906-913
[6]   A systematic review of trial-level meta-analyses measuring the strength of association between surrogate end-points and overall survival in oncology [J].
Haslam, Alyson ;
Hey, Spencer P. ;
Gill, Jennifer ;
Prasad, Vinay .
EUROPEAN JOURNAL OF CANCER, 2019, 106 :196-211
[7]   The Strength of Association Between Surrogate End Points and Survival in Oncology A Systematic Review of Trial-Level Meta-analyses [J].
Prasad, Vinay ;
Kim, Chul ;
Burotto, Mauricio ;
Vandross, Andrae .
JAMA INTERNAL MEDICINE, 2015, 175 (08) :1389-1398
[8]   Lomustine and Bevacizumab in Progressive Glioblastoma [J].
Wick, Wolfgang ;
Gorlia, Thierry ;
Bendszus, Martin ;
Taphoorn, Martin ;
Sahm, Felix ;
Harting, Inga ;
Brandes, Alba A. ;
Taal, Walter ;
Domont, Julien ;
Idbaih, Ahmed ;
Campone, Mario ;
Clement, Paul M. ;
Stupp, Roger ;
Fabbro, Michel ;
Le Rhun, Emilie ;
Dubois, Francois ;
Weller, Michael ;
von Deimling, Andreas ;
Golfinopoulos, Vassilis ;
Bromberg, Jacoline C. ;
Platten, Michael ;
Klein, Martin ;
van den Bent, Martin J. .
NEW ENGLAND JOURNAL OF MEDICINE, 2017, 377 (20) :1954-1963
1