FDA clears Darzalex split-dosing regimen

The US Food and Drug Administration has approved a split-dosing regimen for Darzalex (daratumumab), providing healthcare professionals and patients with multiple myeloma an option to split the first infusion over two consecutive days.

Darzalex is marketed by US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Janssen pharma companies, under a licensing deal with Denmark’s biotech firm Genmab (OMX: GEN). The drug generated sales of $2.03 billion in 2018.

The FDA approval is based on data from the Phase 1b EQUULEUS (MMY1001) clinical study, which demonstrated Darzalex pharmacokinetic (PK) concentrations were comparable at the end of weekly dosing, regardless of whether the first dose was administered as a split infusion or as a single infusion.