U.S. Food and Drug Administration anticancer drug approval trends from 2016 to 2018 for lung, colorectal, breast, and prostate cancer

Approvals in 2018: a histology-agnostic new molecular entity, novel end points and real-time review

(2019) Gideon M. Blumenthal et al.   Nature Reviews Clinical Oncology

Characteristics of non-randomised studies using comparisons with external controls submitted for regulatory approval in the USA and Europe: a systematic review

(2019) Sarah Goring et al.   BMJ Open

Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval

(2019) Bishal Gyawali et al.   JAMA Internal Medicine

Real-world Evidence—What Does It Really Mean?

(2019) Chadi Nabhan et al.   JAMA Oncology

Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies

(2019) Aviv Ladanie et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY

NICE, the NHS, and Cancer Drugs

(2018) Andrew Dillon et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

A systematic review of trial-level meta-analyses measuring the strength of association between surrogate end-points and overall survival in oncology

(2018) Alyson Haslam et al.   EUROPEAN JOURNAL OF CANCER

First FDA Approval Agnostic of Cancer Site — When a Biomarker Defines the Indication

(2017) Steven Lemery et al.   NEW ENGLAND JOURNAL OF MEDICINE

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13

(2017) Courtney Davis et al.   BMJ-British Medical Journal

Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13

(2017) Courtney Davis et al.   BMJ-British Medical Journal

An Important Step Forward for Biosimilars in Cancer Treatment

(2017) Stephen M. Schleicher et al.   JAMA Oncology

Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines

(2017) Sebastian Salas-Vega et al.   JAMA Oncology

Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT)

(2016) Fabrice Barlesi et al.   LANCET

Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration's Approval of Oncology Drugs

(2016) Chul Kim et al.   MAYO CLINIC PROCEEDINGS

An appraisal of drug development timelines in the Era of precision oncology

(2016) Denis Leonardo Jardim et al.   Oncotarget

The Strength of Association Between Surrogate End Points and Survival in Oncology

(2015) Vinay Prasad et al.   JAMA Internal Medicine

An analysis of FDA-approved drugs for oncology

(2014) Michael S. Kinch   DRUG DISCOVERY TODAY

A review of economic impact of targeted oral anticancer medications

(2013) Chan Shen et al.   Expert Review of Pharmacoeconomics & Outcomes Research

The economic pressures for biosimilar drug use in cancer medicine

(2012) Paul Cornes   Targeted Oncology

Accelerated Approval of Oncology Products: The Food and Drug Administration Experience

(2011) John R. Johnson et al.   JNCI-Journal of the National Cancer Institute

New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)

(2008) E.A. Eisenhauer et al.   EUROPEAN JOURNAL OF CANCER