Pink Sheet 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


Avastin Decision Leaves Lingering Uncertainty As To Threshold Level Of Progression-Free Survival Benefit

Executive Summary

In her memo revoking Avastin’s metastatic breast cancer claim, FDA Commissioner Hamburg declines to adopt a “bright-line” cutoff of median PFS improvement that would be necessary to establish efficacy, despite industry’s desire for more certainty about the threshold for approval.


Related Content

The Magnitude Matters: GSK Approvals Show How To Use PFS After Other Drugs Show Survival
Cancer Trials Should Show Minimum 20% Overall Survival Benefit, ASCO Suggests
Genentech Thinks Pertuzumab Will Escape Avastin Problem, Despite Similarities
Avastin Point/Counterpoint: Hamburg Responds To Genentech’s Arguments On Breast Cancer Claim
Avastin Loses Its Breast Cancer Claim; FDA’s Hamburg Opts For Withdrawal Over Restrictions
Avastin Debate Could Provide Clarity On Use Of Progression-Free Survival Endpoints
Avastin Breast Cancer Dispute Centers On “Magnitude Of Benefit” Questions


Related Companies




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