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

Enriched Trials Not Just About Marker-Positive Patients, FDA Says

Executive Summary

Without clear-cut evidence that a drug will not work in patients without a predictive marker, enrichment strategies should allow for collecting some data in the marker-negative population, FDA says in draft guidance.

You may also be interested in...



Will Portola’s Betrixaban Data Pass Muster With FDA?

Portola says that it does not expect it will need to do a second Phase III study to get FDA approval for betrixaban, after missing major endpoint in APEX, but analysts have doubts.

Two Approaches To PD-1 Blocker Pediatric Studies Could Help Clarify Biomarker’s Role

Merck plans to enrich its Phase II study for MK-3475 with patients whose tumors express PD-L1; Bristol would take all comers in its Phase I/II trial of nivolumab.

On The Trail Of Specifics: Industry Critiques Draft Enrichment Guidance

When and how to incorporate marker-negative patients into enriched clinical trials remains undefined for drug companies, which appear accepting of limited indications for marker-positive patients.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS054993

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