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


Avastin’s Breast Cancer Approval Followed CDER Rift On Efficacy

Executive Summary

The Center for Drug Evaluation and Research is expected to present a united front supporting withdrawal of Avastin’s (bevacizumab) metastatic breast cancer claim at a June 28-29 hearing.

You may also be interested in...

FDA “Regulatory Flexibility” On Accelerated Approval Must Result In Some Withdrawals

If all drugs cleared for accelerated approval succeed in their confirmatory studies, then FDA is being overly conservative in its use of the expedited approval pathway, FDA Office of Hematology and Oncology Products Director Richard Pazdur says at the AACR annual meeting.

Perjeta, Avastin Breast Cancer Approvals Are A Study In Contrasts

Pertuzumab’s approval came almost a year after FDA and Genentech battled over the future of bevacizumab’s breast cancer claim at an unprecedented public hearing. While both oncologic agents were approved on the basis of a median progression-free survival benefit exceeding five months, the regulatory similarities end there.

FDA Oncology Panel To Weigh Independent Review Of PFS Event Subset

The Oncologic Drugs Advisory Committee’s July 24 meeting to discuss the merits of independent radiological review of progression assessments in a pre-specified subgroup of patients, instead of 100% of all assessments, comes three years after the agency signaled it was open to considering such an approach.

Related Content





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