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

Failed ALTTO Breast Cancer Trial Casts Doubt On pCR Marker

This article was originally published in The Pink Sheet Daily

Executive Summary

New surrogate marker used to speed development and approval of breast cancer drugs fails to match with better outcomes in ALTTO breast cancer study of Tykerb with Herceptin, featured in ASCO plenary session. Results have “profound implications” for drug development, says outgoing ASCO president Clifford Hudis.

You may also be interested in...



I-SPY Graduates: Where Are They Now?

Five neoadjuvant breast cancer regimens have been tested successfully in I-SPY Phase II program, but three have not moved on to sponsor-driven pivotal testing and the I-SPY 3 master protocol has yet to be used.

Life After I-SPY Graduation: Neratinib Likely To Be Tested With Roche’s Perjeta

I-SPY 2 investigators are buoyed by “strong signal” for neratinib in high-risk subgroup in adaptive design study. Investors, however, are underwhelmed by results.

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.

Topics

Related Companies

UsernamePublicRestriction

Register

PS077346

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