Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Cancer Drug Endpoints: ctDNA Promising But Presents Many Challenges, Experts Say

Executive Summary

To validate change in circulating tumor DNA as an early endpoint predictive of longer-term outcomes, academia, industry and regulators must harmonize data collection for trials in early-stage disease, a Friends of Cancer Research white paper states.

You may also be interested in...



FDA Cancer Center’s New ‘Projects’ Focus On Early Endpoints; Asian American, Native Hawaiian Populations

Launched in 2023, Project Endpoint focuses on advancing understanding of early, novel endpoints, while Project ASIATICA aims to bring greater awareness of challenges and health disparities faced by Asian American, Native Hawaiian, and Other Pacific Islander patients with cancer.

Cancer Drug Endpoints: More Standardization Needed In ctDNA Assessments, US FDA Says

Circulating tumor DNA needs to be prospectively incorporated into trials to assess whether it correlates with long-term outcomes. More standardization in assays and when the biomarker is measured would strengthen analyses of data across studies, FDA officials said.

ctDNA Can Be Used For Patient Selection and Enrichment, But Not As Early Efficacy Endpoint, US FDA Says

More data are required to establish circulating tumor DNA, a blood biomarker, as reasonably likely to predict benefit on long-term outcomes in early-stage, solid tumor trials, agency says in new draft guidance.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS145257

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel