FDA OKs Split-Dosing Regimen for Multiple Myeloma Treatment


The new approval allows for daratumumab (Darzalex) to be administered as a split infusion over 2 consecutive days.

Officials with the FDA have approved a split-dosing regimen for Janssen Pharmaceuticals’ daratumumab (Darzalex), a therapy used to treat patients with multiple myeloma, according to a press release.

The revised label allows for daratumumab (Darzalex) to be administered as a split infusion over 2 consecutive days.

Daratumumab was first approved in November 2015 as the first and only CD38-directed antibody for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double refractory to both.

The latest approved split-dosing regimen is based on data from the phase 1b EQUULEUS (MMY1001) clinical study, which evaluated daratumumab in combination with various treatment regimens. The study 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. According to the findings, splitting the first dose of daratumumab over 2 consecutive days effectively reduced the duration of the first infusion and resulted in a similar rate and pattern of infusion reactions.

Daratumumab is also indicated:

  • In combination with bortezomib, melphalan, and prednisone for patients with multiple myeloma who are ineligible for autologous stem cell transplant.
  • In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for patients with multiple myeloma who have received at least 1 prior therapy.
  • In combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least 2 prior therapies, including lenalidomide and a PI.

No new safety events were observed with a split first dose, according to Janssen. Daratumumab’s split-dosing regimen is also approved in Canada and the European Union.

“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 for Janssen Research & Development, said in a statement. “We are committed to exploring options that may improve the overall treatment experience for patients.”


US FDA Approves Darzalex (daratumumab) Split-Dosing Regimen [news release]. Janssen. https://www.janssen.com/us-fda-approves-darzalex-daratumumab-split-dosing-regimen. Accessed February 12, 2019.

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