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FDA approves daratumumab split-dosing regimen in multiple myeloma
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The FDA approved a split-dosing regimen for daratumumab that will allow the first infusion to be administered over two consecutive days for patients with multiple myeloma, according to a press release from the drug’s manufacturer.
The approval was based on data from the phase 1b EQUULEUS trial that showed comparable pharmacokinetic concentrations of daratumumab (Darzalex, Janssen Pharmaceuticals) at the end of a weekly regimen regardless of whether the initial 16 mg/kg dose was given as a single infusion or over a 2-day period.
Researchers observed no changes in the safety profile of daratumumab when administered initially as a split or single infusion, and no new safety events with a split initial dose.
Daratumumab is the only CD38-directed antibody approved for treatment of multiple myeloma, according to the manufacturer. Splitting the first dose could benefit patients by reducing infusion time.
“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,” Craig Tendler, MD, vice president of clinical development and global medical affairs at Janssen Research & Development LLC, said in a press release. “We are committed to exploring options that may improve the overall treatment experience for patients.”