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

Can Roche Make A Case For Avastin In Brain Cancer Based On Quality Of Life?

Executive Summary

With two trials failing to show a survival advantage in first-line glioblastoma, the company must go to FDA with a progression-free survival benefit and quality-of-life data from one trial to support its accelerated approval in the advanced setting.

You may also be interested in...



Avastin QoL Data In First-Line Glioblastoma Muddy Expansion Plans

Genentech’s bevacizumab was associated with improved maintenance of baseline quality of life and performance status in a confirmatory trial conducted under accelerated approval, but an NCI-funded study found higher rates of neurocognitive decline, increased symptom severity and decline in health-related quality of life.

Avastin Takes One Step Forward, One Step Back At ASCO

Genentech’s bevacizumab was the subject of one study supporting use in cervical cancer and one failing to show an effect in first-line brain cancer. A separate study repeated the disappointing brain cancer results, but the sponsor sees a silver lining in the quality of life dataset.

Can Social Media Help Validate Patient-Reported Outcomes? FDA Reviewer Gives “Resounding Yes”

Work needs to be done to allow for the use of social media to support content validity of patient-reported outcomes, but one FDA endpoints reviewer says there is a place for social media to work alongside traditional methods of validating PROs.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS055398

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