The U.S. Food and Drug Administration (FDA) has approved daratumumab (Darzalex) in combination with dexamethasone plus lenalidomide or bortezomib for the treatment of patients with multiple myeloma who have received at least 1 prior therapy.1
Approval of the supplemental Biologics License Application, which was submitted to the FDA in August 2016, was based on findings from 2 clinical studies. The phase 3 POLLUX trial (ClinicalTrials.gov Identifier: NCT02076009) showed that adding daratumumab to 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) demonstrated that a triplet regimen containing daratumumab, bortezomib, and dexamethasone reduced the risk of progression or death by 61% compared with bortezomib plus dexamethasone in patients with multiple myeloma who received a median of 2 therapies (HR, 0.39; 95% CI, 0.28-0.53; P < .0001).
Both studies showed that the safety of daratumumab combination therapy was consistent with the known safety profiles of daratumumab monotherapy and lenalidomide/bortezomib plus dexamethasone.
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The recommended dose of daratumumab is 16 mg/kg administered as an intravenous infusion. In combination with lenalidomide and dexamethasone, daratumumab should be given weekly for weeks 1 to 8, every 2 weeks for weeks 9 to 24, and then every 4 weeks until disease progression. When administered with bortezomib and dexamethasone, clinicians should give daratumumab weekly for weeks 1 to 9, every 3 weeks for weeks 10 to 24, and every 4 subsequent weeks until disease progression.
- Darzalex (daratumumab) approved by U.S. FDA in combination with two standard of care regimens for the treatment of patients with multiple myeloma who have received at least one prior therapy. Janssen website. http://www.multivu.com/players/English/7979851-janssen-darzalex-combo-fda-approval/. Updated November 21, 2016. Accessed November 21, 2016.