FDA Approves Isatuximab-irfc Combo Therapy for Adults With MM
On March 31, 2021, the FDA approved isatuximab-irfc (Sarclisa; sanofi-aventis US) combined with carfilzomib and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma (MM) given 1 to 3 previous lines of therapy.
This approval was based on safety and efficacy data from the multi-center, open-label, phase 3 IKEMA clinical trial. In this study, 302 patients with relapsed and/refractory MM who had received 1 to 3 prior lines of therapy were randomized in a 3:2 ratio to receive isatuximab-irfc plus carfilzomib and dexamethasone (Isa-Kd) or carfilzomib and dexamethasone (Kd).
The main efficacy end point was progression-free survival (PFS), assessed by an independent response committee. The median PFS was not reached in the Isa-Kd arm and was 20.27 months (95% CI, 15.77-NR) in the Kd arm (HR 0.548; 95% CI, 0.366-0.822; P = .0032), representing a 45% reduction in the risk for disease progression or death in patients treated with Isa-Kd versus Kd.
The most common (≥20%) adverse events in patients receiving isatuximab plus carfilzomib and dexamethasone were upper respiratory tract infection, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, dyspnea, insomnia, bronchitis, cough, and back pain.—Hina Porcelli
Source: US Food and Drug Administration. FDA approves isatuximab-irfc for multiple myeloma. Updated April 1, 2021. www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-isatuximab-irfc-multiple-myeloma. Accessed April 1, 2021.