Merck’s Injectable Version of Blockbuster Cancer Drug Keytruda Wins FDA Approval

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 of the indications covered by the original infused version of the drug. The injectable formulation will be marketed under the brand name Keytruda Qlex. Merck said this new product will become available in late September.

Keytruda belongs to a class of drugs called checkpoint inhibitors, antibodies