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

Perjeta, Avastin Breast Cancer Approvals Are A Study In Contrasts

Executive Summary

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.

You may also be interested in...



Neoadjuvant Surrogate Endpoint Is Tough Sell, But FDA Panel Says Perjeta Worth A Chance

Despite concerns about accelerated approval on the basis of pathological complete response, which has not yet been correlated with improvements in longer-term outcomes, FDA panelists say the large body of efficacy and safety data supporting Genentech’s pertuzumab makes it worth the regulatory risk.

Roche Oncology Turns In A Third Quarter To Rival The Good Old Days

Roche put up improved sales figures reflecting a 9% increase in oncology sales so far in 2012 and elaborated on its plan for continued growth in the face of eventual generic competition.

Genentech’s Perjeta Clears FDA Despite Unresolved Manufacturing Issues

In approving for marketing a finite supply of pertuzumab, FDA determined that the benefit of making a new breast cancer treatment available outweighs the risk that the drug could go into shortage due to production problems. The manufacturing concerns led to a split within the agency on the question of approval, with CDER Director Woodcock making the final call.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS054538

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