Healthcare company Janssen Pharmaceutical Companies of Johnson & Johnson revealed on Tuesday the receipt of approval from the US Food and Drug Administration (FDA) for a split-dosing regimen of DARZALEX (daratumumab) over two consecutive days in patients with multiple myeloma, an incurable blood cancer.

This US FDA approval is based on data from the company's 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.

In conjunction, the split-dosing regimen for DARZALEX is based on data from the company's global, multi-arm, Phase 1b EQUULEUS (MMY1001) study in multiple myeloma, which evaluated DARZALEX in combination with various treatment regimens. Splitting the first dose of DARZALEX over two consecutive days effectively reduced the duration of the first infusion and resulted in a similar rate and pattern of infusion reactions.

The data from the study demonstrated that DARZALEX concentrations were comparable at the end of weekly dosing regardless of whether the first 16 mg/kg dose was administered as a split infusion or single first infusion. The safety profile of DARZALEX was comparable when administered initially as a split or single dose and no new safety events were observed with a split first dose, disclosed the company.

According to the company, the US FDA approval for the DARZALEX initial infusion split-dosing regimen follows Canada and the EU.