Torisel Review Uncovers Protocol Violations That Extended PDUFA Date

This article was originally published in Pharmaceutical Approvals Monthly

01 Nov 2007
News

Tamra Sami tamra.sami@informa.com

Executive Summary

Wyeth’s failure to follow protocol-defined RECIST criteria for measuring tumor response in the pivotal trial for its renal cell carcinoma therapy Torisel was the reason that the drug’s user fee date was extended, according to FDA review documents.

Already Registered? Sign in to continue reading.

New to Pink Sheet? Start a free trial today!

Table
View full table

Topics

Industries
BioPharmaceutical

ASK THE ANALYST
Email

Print
Bookmark
Share

Tags:

BioPharmaceutical

You must sign in to use this functionality

Authentication.SignIn.HeadSignInHeader

PS003697

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 enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel

PS003697

All set! This article has been sent to my@email.address.

All fields are required. For multiple recipients, separate email addresses with a semicolon.

Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.

Torisel Review Uncovers Protocol Violations That Extended PDUFA Date

News

Executive Summary

Topics

You must sign in to use this functionality

Authentication.SignIn.HeadSignInHeader

Register

Ask The Analyst

Email Article

Sign In To Set a Search Alert