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 Breast Cancer Approval Memo Comes Back To Haunt FDA’s Pazdur

Executive Summary

Reflected in the regulatory struggle over Avastin’s (bevacizumab) metastatic breast cancer claim is the uncertainty underlying drug approval decisions for FDA and sponsors, laying bare the sometimes tenuous evidence with which the agency has to work.

You may also be interested in...



“Not Another Avastin,” FDA Panel Warns Genentech At Perjeta Review

Under questioning from FDA’s Richard Pazdur, VP Sandra Horning says company would be willing to withdraw pertuzumab’s neoadjuvant indication if results from ongoing adjuvant study are “clearly negative”; advisory committee members say they expect sponsor to bow out more gracefully than it did in the fight over bevacizumab’s breast cancer claim.

Oncology Drug Applications Migrate As Part Of FDA's Reorganization Of OODP

Many NDAs, BLAs and INDs for cancer drugs are being reassigned to new review divisions as part of a reorganization of FDA’s Office of Oncology Drug Products.

Oncology Drug Applications Migrate As Part Of FDA's Reorganization Of OODP

Many NDAs, BLAs and INDs for cancer drugs are being reassigned to new review divisions as part of a reorganization of FDA’s Office of Oncology Drug Products.

Related Content

Topics

UsernamePublicRestriction

Register

PS053604

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