FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
On July 9, 2026, the FDA approved isatuximab-irfc (Sarclisa Escena; Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma across three combination-regimen indications: with pomalidomide/dexamethasone after ≥1 prior line including lenalidomide and a proteasome inhibitor; with carfilzomib/dexamethasone for relapsed/refractory disease after 1–3 prior lines; and with bortezomib/lenalidomide/dexamethasone for newly diagnosed, transplant-ineligible adults.
Regulatory approval (FDA)
Date: 2026-07-09
The FDA approved isatuximab-irfc (Sarclisa Escena; Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma indications.
Approved indications (subcutaneous isatuximab-irfc):
- With pomalidomide + dexamethasone for adult patients with multiple myeloma who received ≥1 prior line including lenalidomide and a proteasome inhibitor.
- With carfilzomib + dexamethasone for adult patients with relapsed/refractory multiple myeloma after 1–3 prior lines.
- With bortezomib + lenalidomide + dexamethasone for adult patients with newly diagnosed multiple myeloma not eligible for autologous stem cell transplant.
Evidence cited in the FDA communication
- IRAKLIA (NCT05405166): Open-label non-inferiority trial (n=531) comparing subcutaneous (on-body delivery system) vs IV isatuximab-irfc, both with pomalidomide/dexamethasone. ORR: 71.1% (95% CI 65.2–76.5) SC vs 70.5% (95% CI 64.7–75.9) IV. Ctrough GMR (SC/IV): 1.53 (90% CI 1.32–1.78).
- IZALCO (NCT05704049): Phase 2 (n=74) with carfilzomib/dexamethasone; ORR 79.7% (95% CI 68.8–88.2).
- IsaSocut (NCT05889221): Single-arm phase 2 (n=74) with bortezomib/lenalidomide/dexamethasone; ORR 97.3% (95% CI 90.6–99.7).
Safety and dosing highlights
Label warnings/precautions include hypersensitivity/administration reactions, neutropenia, infections, secondary primary malignancies, laboratory test interference, and embryo-fetal toxicity. Recommended dose: 1,400 mg SC via CirCLIQ OBDS or manual administration, in combination with specified regimens. Full prescribing information is to be posted on Drugs@FDA.