Merck Gains FDA Approval for One-Minute Keytruda Cancer Shot
The new subcutaneous formulation aims to improve patient convenience and protect the blockbuster drug's revenue ahead of its 2028 patent cliff.
Merck & Co. has secured a pivotal approval from the U.S. Food and Drug Administration (FDA) for Keytruda Qlex, a new subcutaneous version of its blockbuster cancer immunotherapy that can be administered in about one minute. The decision is a significant strategic move for the pharmaceutical giant, aimed at enhancing patient convenience and defending a key revenue stream from looming patent expiration.
The new formulation, which combines the anti-PD-1 therapy Keytruda with a drug delivery technology from Alteogen Inc., has been for which the intravenous version is used, covering 38 types of cancer. This development drastically reduces the administration time from the 30 minutes or more required for an IV infusion, a change expected to lessen the burden on both patients and healthcare facilities.
This approval is a cornerstone of Merck's strategy to mitigate the financial impact of its best-selling drug's patent cliff. The intravenous version of Keytruda, which generated over $25 billion in sales last year, is . The new subcutaneous formulation comes with its own patent protection, providing a potential pathway to retain a significant portion of its market share as cheaper biosimilars for the IV version emerge.
Analysts view the approval as a competitive necessity, though questions remain about its ability to fully insulate the franchise. The convenience of a one-minute shot is a clear advantage. Merck has stated it expects 30% to 40% of Keytruda users to switch to the new version within two years. However, the market edge could be blunted as many patients receive Keytruda in combination with other IV-administered treatments, such as chemotherapy. "The market edge of SC Keytruda may be dulled by combination agents... that still require intravenous administration," .
Merck has announced it will price Keytruda Qlex 'at parity' with the intravenous version, removing cost as a barrier to adoption. The company plans to make the new formulation available in the U.S. by late September 2025. The approval was based on data from a pivotal study that showed the subcutaneous version had comparable efficacy and safety to its IV counterpart, including similar overall response rates and survival outcomes.