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

Genentech resubmits Avastin for breast cancer

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genentech expects a six-month review for its resubmitted Avastin (bevacizumab) sBLA for first-line treatment for metastatic breast cancer in combination with paclitaxel. The firm announced the resubmission Aug. 24. FDA requested an independent review of patient scans for progression-free survival in a "complete response" letter it sent to the firm Sept. 8. Genentech said the independent review results were consistent with its earlier positive findings...
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS003646

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

Cancel