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

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

Executive Summary

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as reasonably likely to predict benefit on long-term outcomes in early-stage, solid tumor trials, agency says in new draft guidance.

You may also be interested in...



Biomarker Work Needs To Start Early In Drug Development Programs, US FDA Says

Companies often do not focus on biomarker development and validation until too late in the game, FDA officials said at a recent Duke-Margolis meeting; experts cited the need for precompetitive work and public-private collaborations with an emphasis on early engagement, data sharing and transparency.

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

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.

Bladder Cancer: More Questions Than Answers With pCR Endpoint

Pathologic complete response eventually may be a surrogate endpoint for survival, but researchers and the US FDA outlined several problems that must be resolved first.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS146125

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