The US Food and Drug Administration (FDA) has approved a 2-part dosing regimen for daratumumab (Darzalex), which is indicated for the treatment of multiple myeloma.
Health care providers and patients with multiple myeloma now have the option to administer or receive the first dose of daratumumab in 2 infusions given over 2 consecutive days.
"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, MD, Vice President, Clinical Development and Global Medical Affairs, Janssen Research & Development, LLC, in a statement. "We are committed to exploring options that may improve the overall treatment experience for patients."
The FDA’s decision was supported by data from the phase 1b EQUULEUS (MMY1001) clinical study. The open-label, non-randomized study included 240 patients with symptomatic multiple myeloma and measurable secretory disease. The results showed that after weekly dosing, the pharmacokinetic concentrations were similar between participants who received the first 16 mg/kg dose as a split infusion and those who received the first dose as a single infusion.
The safety profile was comparable between the groups receiving the split or single infusion. No new safety events were reported with the split first dose.
The split-infusion dosing regimen for daratumumab was approved by regulatory authorities in Canada and the European Union in December 2018.
Daratumumab was first approved by the FDA in 2015. A later approval in 2016
extended the indication for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Subsequently, in 2018, the FDA approved daratumumab in combination
with bortezomib, melphalan, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).