1. Pink Sheet
  2. >>Regulatory Trackers
  3. >>US FDA Performance Tracker

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA Performance Tracker

More from Regulatory Trackers

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Global Pharma Guidance Tracker - May 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.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.