Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


Plea To FDA: Set Realistic Bar For New Breast Cancer Trial Endpoint

Executive Summary

Commenting on FDA’s draft guidance for accelerated approval using a relatively new surrogate marker of pathologic complete response, Roche/Genentech is wary that FDA may expect too high a bar for results. BIO asks FDA to consider safety when evaluating “magnitude of benefit.”

You may also be interested in...

FDA’s Early Breast Cancer pCR Final Guidance Stresses One Trial

Final guidance from FDA on accelerated approval pathway based on pathological complete response in neoadjuvant breast cancer clarifies that one large trial is the “default” for most applications.

Breast Cancer Experts Suggest Minimum Benefit For New pCR Surrogate

Pathologic complete response in neoadjuvant breast cancer trials is reasonably likely to result in better long-term outcomes, but how big the pCR improvement needs to be is a matter of guesswork.

Genentech Resubmits T-DM1 To FDA, This Time With An Overall Survival Benefit

The antibody drug conjugate showed a significant overall survival benefit in HER2-positive metastatic breast cancer in the EMILIA trial, the company announced.

Related Content


Related Companies

Latest Headlines
See All



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