Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Biomarkers In Labeling Lack Clinical Utility Evidence

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA-approved labels for more than 100 drugs feature pharmacogenomic biomarker data, but only one-sixth of those biomarkers are supported by data showing a clear association with health benefits, a JAMA study found. Researchers recommend stricter standards and a standardized pharmacogenomics section of labeling.

You may also be interested in...



Targeted Therapies Have Most Clinically Useful Biomarker Labeling

Pharmacogenetic biomarkers for molecularly targeted therapies are supported by considerably better evidence that they improve patient outcomes than biomarkers in labeling of untargeted drugs, but a JAMA study still found that half of biomarkers in label lacked convincing evidence of clinical utility.

From “Safe Harbor” To Spotlight: Pharmacogenomics Comes Of Age At FDA

An FDA/industry workshop on pharmacogenomics and biomarkers highlighted how far the regulatory system for PKG has evolved. Where industry was afraid to share data with FDA, the conversation is now about how to get the agency the resources it needs to review the data effectively.

Studies Find Limited Support For Genotyping-Guided Warfarin Dosing

The overall message of three trials published recently in The New England Journal of Medicine: “This pharmacogenetic testing has either no usefulness in the initial dosing of vitamin K antagonists or, at best, marginal usefulness, given the cost and effort required to perform this testing,” according to an editorial also in NEJM.

Related Content

Topics

UsernamePublicRestriction

Register

OM003387

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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