Merck Gains FDA Approval for Faster, 2-Minute Keytruda Injection
Subcutaneous version of the blockbuster cancer drug aims to improve patient convenience and defend against looming 2028 patent cliff.
Merck & Co. has secured a pivotal U.S. Food and Drug Administration (FDA) approval for Keytruda Qlex, a new under-the-skin injection of its blockbuster cancer therapy, Keytruda. The new formulation dramatically cuts administration time from a 30-minute intravenous infusion to as little as two minutes, a significant quality-of-life improvement for patients undergoing cancer treatment.
The approval is a key strategic move for Merck as it prepares to defend its most profitable drug from biosimilar competition when its main patent expires in 2028. Keytruda generated nearly $30 billion in revenue for the company in 2024, making the franchise's longevity a critical issue for investors. for most solid tumor indications currently covered by the intravenous version.
Clinical trials demonstrated that the subcutaneous version offered comparable efficacy and safety to the original IV formulation. This allows patients more flexibility, potentially receiving treatment in a doctor's office rather than a specialized infusion center. "The subcutaneous formulation is a proactive strategy and continuous innovation," said Cristian Marulanda, an analyst at BioPharmCatalyst, viewing it as a way to .
While the convenience factor is a clear win for patients, some analysts remain cautious about its long-term commercial defense. The market advantage could be lessened by the fact that many patients receive Keytruda in combination with other drugs, such as chemotherapies, that still require intravenous administration. this could dull the competitive edge of the injection-only option.
Merck is moving swiftly to market, stating that Keytruda Qlex will be available in the U.S. later this month and will be priced on par with the intravenous version. The company projects that 30% to 40% of its current Keytruda patients could switch to the new subcutaneous option within two years of its launch, a transition that will be closely watched by the market as the 2028 patent cliff approaches.