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