FDA Approves Isatuximab-irfc Combination for Relapsed/Refractory Myeloma

Isatuximab-irfc, in combination with carfilzomib and dexamethasone (Isa-Kd), was approved by the U.S. Food and Drug Administration (FDA) on March 31, 2021 for the treatment of adults with relapsed or refractory multiple myeloma (MM) who have received one to three prior lines of therapy.

The approval is based on safety and efficacy data from the phase III IKEMA trial, which randomized 302 patients with relapsed and/or refractory MM who had received one to three previous therapies to receive either Isa-Kd or carfilzomib and dexamethasone alone (Kd). In the Isa-Kd arm, the primary endpoint of progression-free survival (PFS) was not reached, compared with a median PFS of 20.3 months in the Kd arm. Investigators found a 45% reduction in the risk of disease progression or death in patients treated with Isa-Kd compared with those who received Kd alone.

Adverse events present in 20% or more of patients on the IKEMA trial included  upper respiratory tract infection, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, dyspnea, insomnia, bronchitis, cough, and back pain. Hematologic laboratory abnormalities occurring in ≥80% of patients included decreased hemoglobin, lymphocytes, and platelets.

Recommended dosage of Isa-Kd is 10 mg/kg as an intravenous infusion weekly for four weeks, followed by every two weeks until disease progression or unacceptable toxicity.

Source: FDA press release, March 31, 2021.