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

Provenge Survival Data Plagued by Small Study Size, Post hoc Analysis

Executive Summary

The Cellular, Tissue and Gene Therapies Advisory Committee's favorable recommendation on the efficacy of Dendreon's Provenge could give FDA greater confidence in accepting the post hoc survival analysis and approving the cancer vaccine

You may also be interested in...



Provenge set back until 2008

Approval of Dendreon's therapeutic cancer vaccine Provenge (sipuleucel-T) could be based on an interim analysis of an ongoing Phase III study called IMPACT, expected in 2008, CEO Mitchell Gold says during a first quarter conference call May 11. The firm believes it has the necessary cash balance to fund the company through the interim analysis, but would likely seek refinancing prior to resubmitting Provenge to FDA. The update comes after Dendreon was dealt a blow by FDA when the agency issued a "complete response" letter seeking additional efficacy data on the prostate cancer treatment May 8. FDA's action departs from the recommendation by the agency's Cellular, Tissue and Gene Therapies Advisory Committee, which had issued a favorable recommendation on efficacy (1"The Pink Sheet" April 9, 2007, p. 7)...

Provenge set back until 2008

Approval of Dendreon's therapeutic cancer vaccine Provenge (sipuleucel-T) could be based on an interim analysis of an ongoing Phase III study called IMPACT, expected in 2008, CEO Mitchell Gold says during a first quarter conference call May 11. The firm believes it has the necessary cash balance to fund the company through the interim analysis, but would likely seek refinancing prior to resubmitting Provenge to FDA. The update comes after Dendreon was dealt a blow by FDA when the agency issued a "complete response" letter seeking additional efficacy data on the prostate cancer treatment May 8. FDA's action departs from the recommendation by the agency's Cellular, Tissue and Gene Therapies Advisory Committee, which had issued a favorable recommendation on efficacy (1"The Pink Sheet" April 9, 2007, p. 7)...

Provenge Approval Would Include Surveillance For Cerebrovascular Events

A pharmacovigilence study involving roughly 3,000 patients would be conducted by Dendreon to monitor safety events associated with Provenge, if FDA approves the therapeutic cancer vaccine

Related Content

UsernamePublicRestriction

Register

PS048234

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