FDA Approves Isatuximab-irfc Combination Therapy for Multiple Myeloma
Posted: Thursday, April 1, 2021
On March 31, the U.S. Food and Drug Administration (FDA) approved the anti-DC38 monoclonal antibody isatuximab-irfc (Sarclisa) in combination with carfilzomib and dexamethasone for adults with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy.
The FDA approval was grounded on the results of the multicenter, open-label phase III IKEMA clinical trial. The trial enrolled 302 patients with relapsed multiple myeloma from 69 centers in 16 countries. Patients were randomly assigned to receive isatuximab with carfilzomib and dexamethasone or carfilzomib and dexamethasone as the control.
The median progression-free survival was not reached with isatuximab and was 20.3 months with the control. There was a 45% decrease in the risk of disease progression or death when isatuximab was added to the combination treatment. There was no statistically significant difference in the overall response rate, which remained similar at 86.6% with the isatuximab combination versus 82.9% with the control (P = .3859). The rate of complete response was 39.7% with the isatuximab combination and 27.6% with the control. The rate of very good partial response was 33% with the isatuximab combination therapy and 28.5% with the control therapy.
The most frequent adverse reactions occurred in 20% or more of patients given isatuximab. They included upper respiratory tract infection, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, dyspnea, bronchitis, and cough. Serious adverse reactions included pneumonia and upper respiratory tract infections.
The recommended isatuximab dose with carfilzomib and dexamethasone is 10 mg/kg as an intravenous infusion every week for 4 weeks followed by every 2 weeks until disease progression or unacceptable toxicity. For full prescribing information, visit accessdata.fda.gov.