• Sustainability
  • DE&I
  • Pandemic
  • Finance
  • Legal
  • Technology
  • Regulatory
  • Global
  • Pricing
  • Strategy
  • R&D/Clinical Trials
  • Opinion
  • Executive Roundtable
  • Sales & Marketing
  • Executive Profiles
  • Leadership
  • Market Access
  • Patient Engagement
  • Supply Chain
  • Industry Trends

FDA Grants Breakthrough Therapy Designation to Merck Cancer Drug


November 11, 2015.

FDA News reports that FDA has granted breakthrough therapy designation to Merck’s Keytruda, an anti-PD-1 therapy for treating patients with microsatellite instability high metastatic colorectal cancer.

The breakthrough designation is based on Phase 2 data of the drug’s activity in cancers with microsatellite instability, a feature present in cells with certain types of DNA repair defects.

Merck is conducting a Phase 3 study of the drug in a treatment-naïve patient population.

Keytruda (pembrolizumab) previously was granted breakthrough status for advanced melanoma and advanced non-small cell lung cancer.

Related Videos
Related Content