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FDA Approves Split-Dosing Regimen of Therapy for Multiple Myeloma


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ON FEBRUARY 12 , 2019, the U.S. Food and Drug Administration (FDA) approved a split-dosing regimen for daratumumab (Darzalex), providing health-care professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. Daratumumab is a CD38-directed antibody. The approval is based on data from the phase Ib Equuleus (ClinicalTrials.gov identifier NCT01998971 ) clinical study, which demonstrated daratumumab’s 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.

About the Equuleus Trial

THE GLOBAL, multiarm, phase Ib Equuleus study in multiple myeloma evaluated daratumumab in combination with various treatment regimens. 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. Data from the study demonstrated that daratumumab concentrations were comparable at the end of weekly dosing, regardless of whether the first 16 mg/ kg dose was administered as a split infusion or a single first infusion.

The safety profile of daratumumab was comparable when administered initially as a split or single dose, and no new safety events were observed with a split first dose.

Earlier Approvals

THIS APPROVAL follows approvals in Canada and the European Union in December 2018 for the daratumumab initial infusion split-dosing regimen.

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 and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and an immunomodulatory agent. The therapy received additional approvals in November 2016, 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.

In June 2017, daratumumab received approval in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. In May 2018, daratumumab received approval 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, making it the first monoclonal antibody approved for newly diagnosed patients with this disease.

For more information, visit FDA.gov.


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