FDA Approves DARZALEX Split-Dosing Regimen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) 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. The U.S. 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.

"The first infusion of DARZALEX is an important first step in a patient's course of therapy, and this approval provides added flexibility for how patients may receive initial treatment," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Janssen Research & Development. "We are committed to exploring options that may improve the overall treatment experience for patients."

The FDA approval of a split-dosing regimen for DARZALEX is based on data from the 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. 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.

This approval follows approvals in Canada and the European Union in December 2018 for the DARZALEX initial infusion split-dosing regimen.

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