On July 9, 2026, the Food and Drug Administration approved isatuximab-irfc for subcutaneous injection for multiple myeloma indications. The specific indications approved for Isatuximab-irfc are:

• in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor,
• in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, and
• in combination with bortezomib, lenalidomide and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for an autologous stem cell transplant.

Full prescribing information for isatuximab-irfc will be posted on Drugs@FDA.

Efficacy and Safety

Efficacy of isatuximab-irfc administered subcutaneously in combination with pomalidomide and dexamethasone was evaluated in an open-label non-inferiority trial, IRAKLIA (NCT05405166), randomising 531 patients (1:1) to receive either isatuximab-irfc administered subcutaneously with the on-body delivery system (OBDS) or intravenous isatuximab-irfc, in combination with pomalidomide and dexamethasone. The major outcome measures were overall response rate (ORR) as assessed by an Independent Review Committee (IRC) and the pharmacokinetic endpoint of Ctrough at steady state (corresponding to predose at Cycle 6 Day 1). ORR was 71.1% (95% CI: 65.2, 76.5) in the subcutaneous arm and 70.5% (95% CI: 64.7, 75.9) in the intravenous arm. The subcutaneous/intravenous geometric mean ratio (GMR) (90% CI) for observed steady state Ctrough (pre-dose at Cycle 6 day 1) was 1.53 (90% CI: 1.32-1.78).

Efficacy of isatuximab-irfc administered subcutaneously in combination with carfilzomib and dexamethasone was evaluated in IZALCO (NCT05704049), in 74 patients in a phase 2 clinical study in patients with relapsed and/or refractory multiple myeloma. The efficacy outcome measure, ORR by IRC, was 79.7% (95% CI: 68.8, 88.2).

Efficacy of isatuximab-irfc administered subcutaneously in combination with bortezomib, lenalidomide, and dexamethasone was evaluated in 74 patients in IsaSocut (NCT05889221), a single-arm, investigator-sponsored phase 2 clinical study in patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation. The efficacy outcome measure ORR was 97.3% (95% CI: 90.6, 99.7).

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.

Recommended Dosage

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

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

Isatuximab-irfc received orphan drug designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

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Source: FDA