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

Breast Cancer Drugs Need Survival Benefit for Full Approval, Cmtte. Says

Executive Summary

Time to progression is a sufficiently reliable surrogate endpoint for accelerated approval of drug therapies for breast cancer, but not for unqualified regular approval of first-line therapies, FDA's Oncologic Drugs Advisory Committee decided unanimously June 7.

You may also be interested in...



Progression-Free Survival Represents Clinical Benefit, But How Much? – ODAC

While the Oncologic Drugs Advisory Committee generally endorses the idea that progression-free survival can support full approval of first-line therapies in metastatic breast cancer, the panel left FDA with the challenge of qualifying how PFS represents clinical benefit and determining the measure's meaningfulness for regulatory purposes

Progression-Free Survival Represents Clinical Benefit, But How Much? – ODAC

While the Oncologic Drugs Advisory Committee generally endorses the idea that progression-free survival can support full approval of first-line therapies in metastatic breast cancer, the panel left FDA with the challenge of qualifying how PFS represents clinical benefit and determining the measure's meaningfulness for regulatory purposes

Eloxatine Progression-Free Survival Data Not Enough For Colorectal Use

Studies showing an overall survival advantage for Sanofi-Synthelabo's Eloxatine over 5-FU-based chemotherapy would be needed for approval of the agent as first-line therapy for colorectal cancer, FDA's Oncologic Drugs Advisory Committee found March 16.

UsernamePublicRestriction

Register

PS034321

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

Cancel