FDA Approves Daratumumab Regimens for Relapsed Multiple Myeloma

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US Food and Drug Administration
US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least 1 prior line of therapy.1

In November 2015, the FDA granted accelerated approval to daratumumab as monotherapy for patients with multiple myeloma who have received at least 3 prior therapies, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent.

Approval of these combination regimens is based on findings from 2 phase 3 clinical trials, POLLUX and CASTOR. The POLLUX trial (ClinicalTrials.gov Identifier: NCT02076009) demonstrated that daratumumab plus lenalidomide and dexamethasone reduced the risk of disease progression or death by 63% compared with lenalidomide and dexamethasone alone in patients who had received a median of 1 prior line of therapy (hazard ratio [HR], 0.37; 95% CI, 0.27-0.52; P <.0001).

The phase 3 CASTOR trial (ClinicalTrials.gov Identifier: NCT02136134) study showed that adding daratumumab to bortezomib and dexamethasone reduced the risk of progression or death by 61% vs bortezomib plus dexamethasone in patients who received a median of 2 previous therapies (HR, 0.39; 95% CI, 0.28-0.53; P <.0001).

The most frequently reported adverse reactions (incidence ≥20%) in clinical trials were: infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, muscle spasms, back pain, pyrexia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy, and upper respiratory tract infection.

Clinicians should monitor for infusion reactions, neutropenia, and thrombocytopenia. Daratumumab may increase neutropenia and thrombocytopenia induced by background therapy; dose delay may be required to allow recovery of neutrophils and platelets.

The recommended dose of daratumumab is 16 mg/kg intravenously.


1. Daratumumab (Darzalex). U.S. Food and Drug Administration website. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm530249.htm. Updated November 22, 2016. Accessed November 22, 2016.

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