An overview of cancer drugs approved by the US Food and Drug Administration based on the surrogate end point of response rate

EY Chen, V Raghunathan, V Prasad - JAMA internal medicine, 2019 - jamanetwork.com
Importance Approximately one-third of cancer drugs are approved based on response rate
(RR)—the percentage of patients whose tumors shrink beyond an arbitrary threshold …

[HTML][HTML] An overview of platform trials with a checklist for clinical readers

JJH Park, O Harari, L Dron, RT Lester… - Journal of clinical …, 2020 - Elsevier
Objectives The objective of the study was to outline key considerations for general clinical
readers when critically evaluating publications on platform trials and for researchers when …

Systemic treatment of hepatocellular carcinoma: An EASL position paper

J Bruix, SL Chan, PR Galle, L Rimassa, B Sangro - Journal of hepatology, 2021 - Elsevier
The last 5 years have witnessed relevant advances in the systemic treatment of
hepatocellular carcinoma. New data have emerged since the development of the EASL …

Evaluating the evidence behind the surrogate measures included in the FDA's table of surrogate endpoints as supporting approval of cancer drugs

B Gyawali, SP Hey, AS Kesselheim - EClinicalMedicine, 2020 - thelancet.com
Abstract Background In July 2018, the FDA first published a table listing all surrogate
measures that it has used, and may accept for future use, in regulatory approval. However …

[HTML][HTML] Decision making in older adults with cancer

C DuMontier, KP Loh… - Journal of Clinical …, 2021 - ncbi.nlm.nih.gov
Significant progress has been made toward improving the care of older adults with cancer.
As described elsewhere in this Special Series, the evidence base in geriatric oncology has …

The FDA approval of pembrolizumab for patients with TMB> 10 mut/Mb: was it a wise decision? No

V Prasad, A Addeo - Annals of Oncology, 2020 - annalsofoncology.org
Mb. The underlying data from KEYNOTE-158 suggest the cut off is arbitrary and capricious.
Below 10 mut/Mb, pembrolizumab's response rate (RR) is 6.7%. From 10 to 13 mut/Mb, the …

An urgent call to raise the bar in oncology

JJB Schnog, MJ Samson, ROB Gans… - British Journal of Cancer, 2021 - nature.com
Important breakthroughs in medical treatments have improved outcomes for patients
suffering from several types of cancer. However, many oncological treatments approved by …

Progression-free survival: it is time for a new name

B Gyawali, E Eisenhauer, M Tregear… - The Lancet …, 2022 - thelancet.com
Progression-free survival refers to the time from randomisation or initiation of treatment to the
occurrence of disease progression or death. Disease progression is defined by the …

Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross …

H Naci, C Davis, J Savović, JPT Higgins, JAC Sterne… - bmj, 2019 - bmj.com
Objective To examine the design characteristics, risk of bias, and reporting adequacy of
pivotal randomised controlled trials of cancer drugs approved by the European Medicines …

Overall survival benefits of cancer drugs approved in China from 2005 to 2020

Y Zhang, H Naci, AK Wagner, Z Xu, Y Yang… - JAMA network …, 2022 - jamanetwork.com
Importance Of approximately 9 million patients with cancer in China in 2020, more than half
were diagnosed with late-stage cancers. Recent regulatory reforms in China have focused …