Merck announced that the European Commission has approved a subcutaneous formulation of its flagship immunotherapy, KEYTRUDA (pembrolizumab), for all 33 adult indications currently authorized in the EU. The new product, marketed as KEYTRUDA SC, can be administered in as little as one minute by a health‑care provider, a dramatic reduction from the 2‑hour intravenous infusion that has been the standard of care.
The approval removes a regulatory barrier that had confined KEYTRUDA to intravenous use, enabling broader patient access and potentially increasing sales volume. In Q3 2025, KEYTRUDA generated $8.1 billion in revenue—up 10% year‑over‑year—and contributed 47% of Merck’s total worldwide sales of $17.3 billion. The company’s FY 2025 guidance now projects sales of $64.5 billion to $65.0 billion, a slight tightening from the $64.3 billion to $65.3 billion range announced in August, reflecting a more conservative view of the drug’s growth trajectory as exclusivity approaches.
Management highlighted the strategic importance of the subcutaneous format. Dr. Marjorie Green, senior vice president of oncology, said, “KEYTRUDA SC is the first and only subcutaneous immune‑checkpoint inhibitor in Europe, allowing patients to receive therapy in a single minute every three weeks or two minutes every six weeks. This convenience expands access and gives patients more choice of care settings.” CEO Rob Davis added, “The launch of KEYTRUDA SC strengthens our portfolio as we prepare for the eventual loss of exclusivity and underscores our commitment to patient‑focused innovation.”
The subcutaneous formulation leverages berahyaluronidase alfa, a hyaluronidase variant developed by Alteogen Inc., and follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2025. In the United States, a similar product, KEYTRUDA QLEX, received FDA approval in September 2025, underscoring the global momentum behind this delivery platform.
Strategically, the approval positions Merck ahead of competitors that have not yet secured a subcutaneous checkpoint inhibitor in Europe. The convenience of a one‑minute injection is expected to broaden the patient base, potentially offsetting the headwind of impending patent expiry. While foreign‑exchange fluctuations and the broader macro environment remain challenges, the company’s robust gross margin—80.5% in Q3 2024—provides a cushion to absorb any short‑term pricing pressure. The subcutaneous launch is a key element of Merck’s broader pipeline diversification strategy, which includes recent acquisitions such as Verona Pharma and expanded U.S. manufacturing capacity.
Overall, the EU approval of KEYTRUDA SC marks a significant milestone in Merck’s immuno‑oncology strategy, offering a faster, more convenient treatment option that is likely to drive incremental sales and reinforce the company’s leadership position as it navigates the next phase of its flagship drug’s lifecycle.
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