FDA Approves Subcutaneous Isatuximab-irfc

The approval expands subcutaneous use across newly diagnosed and previously treated multiple myeloma.

To report the FDA approval of subcutaneous isatuximab-irfc for multiple myeloma.

Indications: Approved for use in combination with pomalidomide and dexamethasone for patients who have received at least one prior line of therapy that included lenalidomide and a proteasome inhibitor; carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy; and bortezomib, lenalidomide, and dexamethasone for newly diagnosed patients who are not eligible for autologous stem cell transplantation.

In the IRAKLIA trial, the overall response rate was 71% for both subcutaneous and intravenous groups.
In the IZALCO study, the overall response rate was 80%.
In the IsaSocut study, the overall response rate was 97%.

The FDA's approval is based on the efficacy demonstrated in clinical trials for various patient populations with multiple myeloma.

Warnings include hypersensitivity reactions, neutropenia, infections, secondary malignancies, and embryo-fetal toxicity, as stated in the prescribing information.