FDA to Decide on Merck’s Subcutaneous Keytruda in September 2025
The FDA has set a target decision date (PDUFA) of September 23, 2025, for Merck's subcutaneous formulation of Keytruda2.
The new formulation allows for a 2-minute injection, reducing treatment time by approximately 50% compared to the intravenous (IV) version3.
Subcutaneous Keytruda demonstrated non-inferiority to IV Keytruda in pharmacokinetics, efficacy, and safety in the Phase 3 Keynote-D77 trial1.
The subcutaneous formulation showed a 49.7% reduction in patient chair time and a 45.7% reduction in healthcare professional time3.
If approved, Merck aims to switch between 30% and 40% of all Keytruda use to the subcutaneous version, focusing on early-stage patients7.
The application covers all existing solid tumor indications of IV Keytruda.
Merck is currently involved in a patent dispute with Halozyme regarding the subcutaneous formulation technology1.
The European Medicines Agency is also reviewing an application for the subcutaneous version of Keytruda2.
This new formulation represents a significant advancement in cancer care delivery, potentially improving patient experience and treatment center efficiency while maintaining Keytruda's therapeutic efficacy3.
Sources:
1. https://www.oncologypipeline.com/apexonco/elcc-2025-subq-keytruda-heads-towards-approval
2. https://seekingalpha.com/news/4425797-merck-subcutaneous-keytruda-gains-fda-target-date-september
3. https://www.stocktitan.net/news/MRK/merck-s-investigational-subcutaneous-pembrolizumab-with-0e9bg061bwfc.html