A survey of breakthrough therapy designations

被引:27
作者
Aggarwal, Saurabh [1 ,2 ]
机构
[1] Novel Hlth Strategies LLC, Bethesda, MD 20814 USA
[2] Inst Global Policy Res, Washington, DC USA
关键词
HEPATITIS-C; GENOTYPE; TREATMENT-NAIVE; DACLATASVIR; ASUNAPREVIR; INHIBITOR; INFECTION; RIBAVIRIN; TRIAL;
D O I
10.1038/nbt.2864
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
As of last month, 41 products have been granted breakthrough therapy designations by the US Food and Drug Administration-drugs against cancer, hepatitis C and monogenetic diseases predominate.
引用
收藏
页码:323 / 330
页数:8
相关论文
共 38 条
[21]   Cost-effectiveness of adding rituximab to fludarabine and cyclophosphamide for the treatment of previously untreated chronic lymphocytic leukemia [J].
Hornberger, John ;
Reyes, Carolina ;
Shewade, Ashwini ;
Lerner, Susan ;
Friedmann, Mark ;
Han, Leona ;
Gutierrez, Hialy ;
Satram-Hoang, Sacha ;
Keating, Michael J. .
LEUKEMIA & LYMPHOMA, 2012, 53 (02) :225-234
[22]  
IMS Health, 2012, TOT UN AUD GLOB PHAR
[23]   Phase 2b Trial of Interferon-free Therapy for Hepatitis C Virus Genotype 1 [J].
Kowdley, Kris V. ;
Lawitz, Eric ;
Poordad, Fred ;
Cohen, Daniel E. ;
Nelson, David R. ;
Zeuzem, Stefan ;
Everson, Gregory T. ;
Kwo, Paul ;
Foster, Graham R. ;
Sulkowski, Mark S. ;
Xie, Wangang ;
Pilot-Matias, Tami ;
Liossis, George ;
Larsen, Lois ;
Khatri, Amit ;
Podsadecki, Thomas ;
Bernstein, Barry .
NEW ENGLAND JOURNAL OF MEDICINE, 2014, 370 (03) :222-232
[24]  
Kuznar W., IBRUTINIB INDUCES RA
[25]  
Lawitz E, 2013, 64 ANN M AM ASS STUD
[26]   Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial [J].
Lawitz, Eric ;
Poordad, Fred F. ;
Pang, Phillip S. ;
Hyland, Robert H. ;
Ding, Xiao ;
Mo, Hongmei ;
Symonds, William T. ;
McHutchison, John G. ;
Membreno, Fernando E. .
LANCET, 2014, 383 (9916) :515-523
[27]   Tafenoquine plus chloroquine for the treatment and relapse prevention of Plasmodium vivax malaria (DETECTIVE): a multicentre, double-blind, randomised, phase 2b dose-selection study [J].
Llanos-Cuentas, Alejandro ;
Lacerda, Marcus V. ;
Rueangweerayut, Ronnatrai ;
Krudsood, Srivicha ;
Gupta, Sandeep K. ;
Kochar, Sanjay K. ;
Arthur, Preetam ;
Chuenchom, Nuttagarn ;
Moehrle, Joerg J. ;
Duparc, Stephan ;
Ugwuegbulam, Cletus ;
Kleim, Joerg-Peter ;
Carter, Nick ;
Green, Justin A. ;
Kellam, Lynda .
LANCET, 2014, 383 (9922) :1049-1058
[28]  
Lowery M., 2013, DRUG TOPICS
[29]   Institute of Medicine Recommendations for The Prevention and Control of Hepatitis B and C [J].
Mitchell, Abigail E. ;
Colvin, Heather M. ;
Beasley, R. Palmer .
HEPATOLOGY, 2010, 51 (03) :729-733
[30]  
National Institute for Health Service, 2013, ASF ALF HYP