FDA Alert: Split-Dosing Daratumumab Regimen Approved for Multiple Myeloma

By David Costill
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The FDA has approved a new dosing regimen for daratumumab (Darzalex; Janssen) for the treatment of patients with multiple myeloma, according to a news release.

The newly-approved dosing regimen allows daratumumab to be administered in a split dose, splitting the first infusion over two consecutive days. This reduced administration burden could improve patient access to the treatment.


Myeloma cells. Source: Getty

"The first infusion of [daratumumab] 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, said in the press release. “We are committed to exploring options that may improve the overall treatment experience for patients."

The FDA based its approval for the new dosing regimen on data from the EQUULEUS clinical trials. This Phase1b trial evaluated daratumumab in combination with various other treatments for patients with multiple myeloma. The study showed that when splitting the dose, daratumumab concentrations were similar at the end of weekly dosing—despite the 16mg/kg dose being split into two infusions.

The researchers also found that there were no safety differences when the dose was split.

Daratumumab first received approval in November 2015, and has since been approved in combination with a number of various therapies. Daratumumab is the only CD38-directed antibody approved for the treatment of multiple myeloma, according to the news release.