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

Avastin sBLA Clears Advisory Committee, Faces Quality of Life Hurdle

This article was originally published in The Pink Sheet Daily

Executive Summary

Accelerated approval for glioblastoma multiforme can be based on objective response rate, panel tells FDA.

You may also be interested in...



Avastin Advisory Committee To Assess Validity Of Objective Response Rate Endpoint

FDA questions whether imaging improvements in patients with glioblastoma metaforme are sufficient to denote clinical change.

Schering-Plough's Temodar Clears FDA For First-Line Use In Glioblastoma

Approval of temozolomide was based on a Phase III trial that demonstrated a statistically significant survival benefit in combination with radiotherapy versus radiotherapy alone. Temodar also received full approval for its original indication of anaplastic astrocytoma.

Gliadel Marketing For Newly-Diagnosed Glioma Will Highlight Survival Benefit

Guilford's marketing of Gliadel for use in patients undergoing surgery for newly-diagnosed malignant glioma will highlight the survival benefit, the company said after receiving the supplemental indication

Topics

UsernamePublicRestriction

Register

OM016204

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