Merck & Co. announced on March 27, 2025, its plan to launch a subcutaneously injected version of its blockbuster cancer immunotherapy Keytruda in the U.S. on October 1. The company expects to achieve peak adoption rates for this new version within two years.
The U.S. Food and Drug Administration (FDA) has set a PDUFA date of September 23 for the subcutaneous Keytruda application. This new formulation offers a more convenient administration option compared to the current intravenous version.
This strategic launch is crucial for Merck to mitigate the impact of the upcoming patent expiration for IV Keytruda. A successful transition to the subcutaneous version is expected to help maintain market share and extend the product's lifecycle, reinforcing Merck's oncology leadership.
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