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

Early Study Termination Is Key Issue In ODAC Review Of Pfizer's Sutent For Pancreatic Cancer

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA is asking its Oncologic Drugs Advisory Committee whether sunitinib's risk/benefit profile in pancreatic neuroendocrine tumors is favorable given that early termination of the Phase III trial created uncertainty about the magnitude of its progression-free survival benefit.

You may also be interested in...



Sutent Cleared For Pancreatic Tumors, But With Caveat On Efficacy

FDA approves Pfizer's sunitinib with labeling that states the magnitude of progression-free survival benefit seen in the pivotal study may have been overestimated due to the trial's early termination.

Sutent Cleared For Pancreatic Tumors, But With Caveat On Efficacy

FDA approves Pfizer's sunitinib with labeling that states the magnitude of progression-free survival benefit seen in the pivotal study may have been overestimated due to the trial's early termination.

Sutent Pancreatic Tumor Study Shows Regulatory Pitfalls Of Stopping Early

Pfizer’s development of Sutent (sunitinib) for treatment of pancreatic tumors shows the potential pitfalls sponsors face when they decide to terminate clinical trials early due to positive results.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS072083

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