Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials-Reference-Cited by-同舟云学术

Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials

Published:2018-11-01 Issue:11 Volume:4 Page:1610
ISSN:2374-2437
Container-title:JAMA Oncology
language:en
Short-container-title:JAMA Oncol

Author:

Tibau Ariadna¹,Molto Consolación¹,Borrell Maria¹,Del Paggio Joseph C.²,Barnadas Agustí¹,Booth Christopher M.³⁴⁵,Amir Eitan²

Affiliation:

1. Department of Oncology, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain

2. Division of Medical Oncology and Hematology, Department of Medicine, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada

3. Division of Cancer Care and Epidemiology, Queen’s University Cancer Research Institute, Kingston, Ontario, Canada

4. Department of Oncology, Queen’s University, Kingston, Ontario, Canada

5. Department of Public Health Sciences, Queen’s University, Kingston, Ontario, Canada

Publisher

American Medical Association (AMA)

Subject

Oncology,Cancer Research

Reference6 articles.

1. Applications for FDA approval to market a dew drug: patent submission and listing requirements and application of 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed: final rule.;Food and Drug Administration, HHS;Fed Regist,2003

2. Magnitude of clinical benefit of cancer drugs approved by the US Food and Drug Administration.;Tibau;J Natl Cancer Inst,2018

3. ESMO-Magnitude of Clinical Benefit Scale version 1.1.;Cherny;Ann Oncol,2017

4. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).;Eisenhauer;Eur J Cancer,2009

5. Role of randomized phase III trials in an era of effective targeted therapies.;Sharma;Nat Rev Clin Oncol,2011

Cited by 29 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Clinical value of guideline recommended molecular targets and genome targeted cancer therapies: cross sectional study;BMJ;2024-08-20

2. Application of the ESMO Magnitude of Clinical Benefit Scale to assess the clinical benefit of antibody drug conjugates in solid cancer: a systematic descriptive analysis of phase III and pivotal phase II trials;BMJ Open;2024-06

3. Clinical Value of Molecular Targets and FDA-Approved Genome-Targeted Cancer Therapies;JAMA Oncology;2024-05-01

4. Lessons learned from postmarketing withdrawals of expedited approvals for oncology drug indications;The Lancet Oncology;2024-03

5. Magnitude of effect and sample size justification in trials supporting anti-cancer drug approval by the US Food and Drug Administration;Scientific Reports;2024-01-03