An overview of cancer drugs approved by the US Food and Drug Administration based on the surrogate end point of response rate
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 …
(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
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 …
readers when critically evaluating publications on platform trials and for researchers when …
Systemic treatment of hepatocellular carcinoma: An EASL position paper
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 …
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
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 …
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 …
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
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 …
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 …
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 …
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 …
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 …
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
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 …
were diagnosed with late-stage cancers. Recent regulatory reforms in China have focused …