Split-dosing regimen of daratumumabApril 9, 2019
The US FDA has approved a split-dosing regimen for daratumumab (Darzalex) providing healthcare professionals and patients with multiple myeloma an option to split the first infusion over two consecutive days.
The US FDA approval is based on data from the phase 1b Equuleus clinical study, which demonstrated daratumumab pharmacokinetic 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.
Daratumumab is the first CD38-directed antibody to receive regulatory approval to treat multiple myeloma. In the US, Darzalex (daratumumab) first received FDA approval in November 2015 as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent, Janssen said.