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

Merck, GSK Sarcoma Drugs Bring Different Efficacy Stories To FDA Panel Review

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Oncologic Drugs Advisory Committee will be asked to consider a two-week median progression-free survival benefit with Merck/Ariad’s Taltorvic in the maintenance setting, and a three-month PFS advantage with GSK’s Votrient in second-line treatment.

You may also be interested in...



ASCO Seeks More Aggressive Approach On Limiting Safety Data Collection

The American Society of Clinical Oncology says FDA’s draft guidance on targeted safety data collection is too conservative and inconsistent with the agency’s recommendations from a 2001 guidance on cancer drug clinical trials. ASCO requests the two guidances be harmonized to eliminate the potential for confusion among sponsors and clinical trial investigators.

Cancer Therapies Should Be Held To Higher Bar In Maintenance Setting, ODAC Says

In their review of Merck/Ariad’s Taltorvic (ridaforolimus) for sarcoma patients with stable disease, members of FDA’s Oncologic Drugs Advisory Committee suggested the nature of maintenance therapy necessitates that efficacy be more robust, and toxicities less of a concern, than in the treatment setting.

Accelerated Approval Could Spur Development Of Patient-Reported Outcomes Tools

A subtle takeaway from the Oncologic Drugs Advisory Committee’s March 20 review of GlaxoSmithKline’s Votrient (pazopanib) for treatment of advanced soft tissue sarcoma was that accelerated approval, with a post-marketing requirement to confirm clinical benefit in a difficult-to-treat population, could incentivize sponsors to develop instruments for assessing symptom improvement.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS073892

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