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


FDA Panel Review Of Merck/Ariad’s Sarcoma Drug Could Hinge On Clinical Significance Of Progression-Free Survival Benefit

This article was originally published in The Pink Sheet Daily

Executive Summary

The Oncologic Drugs Advisory Committee will review two drugs for sarcoma indications on March 20: Merck/Ariad’s Taltorvic (ridaforolimus) and GlaxoSmithKline’s Votrient (pazopanib). With a three-week median PFS advantage in its pivotal trial, ridaforolimus could face the same questions about clinically significant benefit that led to revocation of Avastin’s metastatic breast cancer claim.

You may also be interested in...

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

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.

Avastin Debate Could Provide Clarity On Use Of Progression-Free Survival Endpoints

Rather than damaging the use of progression-free survival as an endpoint in oncology clinical trials, as some have feared, the battle over Avastin’s (bevacizumab) metastatic breast cancer claim could give sponsors some clarity as to how FDA expects the magnitude of PFS benefit to be defined.

Ariad Comes Of Age With Oncology Drugs, Readies For Commercial Leap

With positive signs for its stable of cancer drugs, including an imminent filing for the sarcoma candidate ridaforolimus, Ariad Pharmaceuticals Inc. is nearing the turning point from a development to a commercial company.

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