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

 
• By Sue Sutter

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.

Merck & Co. Inc. and development partner Ariad Pharmaceuticals Inc. face a seemingly formidable task at the Oncologic Drugs Advisory Committee’s March 20 review of their investigational sarcoma therapy Taltorvic (ridaforolimus).

The companies will have to persuade ODAC that a statistically significant 26% improvement in progression-free survival, with a mean PFS...

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More from Regulatory Trackers

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
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The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
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Global Pharma Guidance Tracker - June 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.