Medtech Insight is part of the Business Intelligence Division 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


Never Again? Why the Avastin Hearing May Be One of a Kind

This article was originally published in RPM Report

Executive Summary

The two-day “streamlined withdrawal” hearing for Genentech’s breast cancer indication for Avastin was an unprecedented regulatory event. Based on how badly it went for the sponsor—and how uncomfortable it was for FDA—there may not be too many imitators any time soon.

Related Content

Another Vote for Accelerated Approval
How To Withdraw A Drug: FDA’s Final Decision on Avastin
How to Withdraw a Drug: FDA’s Final Decision on Avastin
Avastin and FDA/CMS Coordination: Genentech's Safe Strategy to Save Medicare Coverage
Accelerated Withdrawal in Action: The Avastin Hearing Process
The Avastin Docket: Few Comments, But Lots of Questions About Implications
FDA's Avastin Breast Cancer Withdrawal Sets New Standard, Deters Drug Development



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