FDA approves Merck’s Keytruda Qlex

The US Food and Drug Administration (FDA) has approved Merck & Co’s (NYSE: MRK) pembrolizumab and berahyaluronidase alfa-pmph (trade name Keytruda Qlex) for subcutaneous injection for adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumab (Keytruda).

Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by South Korea’s Alteogen (Kosdaq: 196170). Keytruda Qlex must be administered by a health care provider (HCP). Merck expects to have Keytruda Qlex available in the USA in late September. F

Keytruda, with sales of around $8 billion in second-quarter 2025, is already the world’s biggest selling drug, accounting for around half of Merck’s revenues. However, as infused Keytruda is slated to lose patent protection in 2028, the subcutaneous formulation will be critical to the pharma giant’s top-line stability.