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

Cancer Clinical Trials: Survival Used As Endpoint 12% Of Time, FDA Reports

Executive Summary

An FDA review of oncology drug approvals during the last eight years indicates that the survival endpoint has been used relatively infrequently to support a growing number of approved indications

You may also be interested in...



Progression-Free Survival Is Good Endpoint For Metastatic NSCLC, Cmte. Says

An endpoint of progression-free survival is appropriate for full approval of first-line non-small cell lung cancer treatments in metastatic cancers, but not for earlier-stage disease, the Oncologic Drugs Advisory Committee concluded Dec. 16

Progression-Free Survival Is Good Endpoint For Metastatic NSCLC, Cmte. Says

An endpoint of progression-free survival is appropriate for full approval of first-line non-small cell lung cancer treatments in metastatic cancers, but not for earlier-stage disease, the Oncologic Drugs Advisory Committee concluded Dec. 16

FDA Revising Accelerated Approval Standard In Oncology; Biomarkers Sought

FDA is changing its accelerated approval guidelines to allow for approval of several different oncologic agents for the same indication under Subpart H procedures, Commissioner McClellan said during the American Society of Clinical Oncology annual meeting in Chicago May 31

UsernamePublicRestriction

Register

PS041952

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