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

On The Trail Of Specifics: Industry Critiques Draft Enrichment Guidance

Executive Summary

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.

You may also be interested in...



User Fees For Biomarker Qualification Might Improve Study Designs

Despite Bob Temple’s assurance that draft enrichment guidance allows companies to exclude biomarker-negative patients, industry asks FDA for more guidance on when they can safely say a biomarker is discriminatory.

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

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marker, enrichment strategies should allow for collecting some data in the marker-negative population, FDA says in draft guidance.

Untargeting Xalkori? Hints Of Efficacy In ALK-Negative Patients Must Be Addressed, FDA Says

FDA approved Pfizer’s lung cancer drug for patients positive for the gene translocation – but review documents show that agency reviewers focused on the efficacy seen in the few ALK-negative patients in the pivotal trial, and want Pfizer to follow up on that signal post-marketing. Regulatory expectations for disproving effect in the non-selected population will be an important issue as more personalized medicines reach the agency.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS055249

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