FDA Approval

FDA Approves Subcutaneous Isatuximab-irfc for Multiple Myeloma Indications

Edited by:
Anthony Calabro, MA

Key Highlights

  • The FDA approved isatuximab-irfc for subcutaneous injection for multiple myeloma indications.
  • In IRAKLIA, subcutaneous isatuximab-irfc plus pomalidomide and dexamethasone had an overall response rate of 71.1% vs 70.5% with intravenous isatuximab-irfc.
  • In IZALCO, subcutaneous isatuximab-irfc plus carfilzomib and dexamethasone had an overall response rate of 79.7%.
  • In IsaSocut, subcutaneous isatuximab-irfc plus bortezomib, lenalidomide, and dexamethasone had an overall response rate of 97.3%.

On July 9, the FDA approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis US LLC) for subcutaneous injection for multiple myeloma indications. The approval covers 3 multiple myeloma regimens. Isatuximab-irfc may be used with pomalidomide and dexamethasone in adults who have received at least 1 prior line of therapy, including lenalidomide and a proteasome inhibitor; with carfilzomib and dexamethasone in adults with relapsed or refractory multiple myeloma after 1 to 3 prior lines of therapy; and with bortezomib, lenalidomide, and dexamethasone in adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.

Efficacy of subcutaneous isatuximab-irfc with pomalidomide and dexamethasone was evaluated in IRAKLIA. This open-label noninferiority trial randomly assigned 531 patients 1:1 to receive either subcutaneous isatuximab-irfc with an on-body delivery system or intravenous isatuximab-irfc, both in combination with pomalidomide and dexamethasone. The major outcome measures were the overall response rate by the Independent Review Committee and the pharmacokinetic endpoint of steady-state Ctrough, corresponding to predose on cycle 6, day 1. The overall response rate was 71.1% in the subcutaneous arm and 70.5% in the intravenous arm. The subcutaneous/intravenous geometric mean ratio for observed steady-state Ctrough was 1.53.

The efficacy of subcutaneous isatuximab-irfc with carfilzomib and dexamethasone was evaluated in IZALCO, a phase 2 study involving 74 patients with relapsed and/or refractory multiple myeloma. The overall response rate by an independent review committee was 79.7%. The efficacy of subcutaneous isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone was evaluated in IsaSocut, a single-arm, investigator-sponsored phase 2 study of 74 patients with newly diagnosed multiple myeloma who were ineligible for stem cell transplantation. The overall response rate was 97.3%.

The prescribing information includes warnings and precautions for hypersensitivity and other administration reactions, neutropenia, infections, secondary primary malignancies, laboratory test interference, and embryo-fetal toxicity.

The recommended isatuximab-irfc dose is 1,400 mg, administered as a subcutaneous injection using the CirCLIQ on-body delivery system or a syringe and infusion set for manual administration, in combination with the specified regimens.

Reference
US Food and Drug Administration. FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications. Published July 9, 2026. Accessed July 15, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications