MedCity News September 21, 2025
Keytruda Qlex, an injectable version of Merck’s cancer immunotherapy, can be administered in minutes compared to the 30 minutes needed to dose the original infused formulation. The FDA approval is based on clinical trial results showing the injectable formulation was comparable to infused Keytruda.
A subcutaneously injected version of Merck cancer immunotherapy Keytruda is now FDA approved, a regulatory decision that gives patients a less burdensome dosing option and provides the pharmaceutical giant a way to retain some market share as the original intravenously infused formulation — its top-selling product — faces patent expirations.
The approval announced Friday covers use of the injectable product in adults and children age 12 and older for 38 solid tumor indications, which is most...
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