The Food and Drug Administration 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 one prior therapy.
The drug was approved last year as 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 current approval of daratumumab (Darzalex) in combination with standard therapy is based on improvement in progression-free survival (PFS) in two phase III trials, the FDA said in a written statement .
In the POLLUX trial, median PFS had not been reached in the daratumumab plus lenalidomide and dexamethasone arm and was 18.4 months among patients getting lenalidomide and dexamethasone alone (HR=0.37; 95% CI: 0.27, 0.52; P less than.0001).
In the CASTOR trial, which compared the combination of daratumumab, bortezomib, and dexamethasone with bortezomib and dexamethasone, the estimated median PFS had not been reached in the daratumumab arm and was 7.2 months in the control arm (hazard ratio, 0.39; 95% confidence interval, 0.28-0.53; P less than .0001).
Updated results for both trials will be presented at the upcoming annual meeting of the American Society of Hematology ( abstract #1150 , abstract #1151 ).
The most frequently reported adverse reactions in POLLUX were infusion reactions, diarrhea, nausea, fatigue, pyrexia, upper respiratory tract infection, muscle spasm, cough, and dyspnea. The most frequently reported adverse reactions in CASTOR were infusion reactions, diarrhea, peripheral edema, upper respiratory tract infection, peripheral sensory neuropathy, cough, and dyspnea.
The recommended dose of daratumumab is 16 mg/kg IV (calculated on actual body weight), the FDA said.
Full prescribing information is available here.
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