Keytruda SC's Phase 3 Clinical data was released on March, 27, 2025.

This Treatment uses Alteogen's berahyaluronidase Alfa(ALT-B4).

Key Point 

• Pharmacokinetic (PK) Data : Non-inferiority was demostrated
  


• Efficacy and Safety : Consistent data was shown in both aspects
  


• Time Efficiency : Administration time was reduced by 49.7%, The overall time spent in the treatment room decreased by 47.4%, and Heathlcare professionals' time was reduced by 45.7%
  


• Approval and Launch Schedule
  
  
  
  • FDA approval target date: Sept. 23, 2025
  
  
  • US expected launch date: Oct. 1, 2025 **
  
  
  
  

 Merck’s Investigational Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Demonstrates Noninferior Pharmacokinetics Compared to Intravenous (IV) KEYTRUDA® (pembrolizumab) in Pivotal 3475A-D77 Trial(MSD)

**Merck plans to  launch US subcutaneous version of Keytruda on October 1(Reuters)