FDA Approves Subcutaneous Isatuximab Across Multiple Indications for Patients With Multiple Myeloma

Clinical Summary: 

• Based on findings from the phase 3 IRAKLIA, phase 3 IZALCO, and phase 1 IsaSocut studies, the FDA has approved subcutaneous isatuximab across three indications for patients with newly diagnosed or relapsed/refractory multiple myeloma.
• Across the supporting studies, subcutaneous isatuximab demonstrated efficacy comparable to the intravenous formulation or high response rates in combination with established treatment regimens while maintaining a safety profile consistent with previous experience.
• This approval expands the use of isatuximab across multiple multiple myeloma treatment settings while providing a more convenient subcutaneous administration option.

On July 9, 2026, the US Food and Drug Administration (FDA) approved subcutaneous isatuximab (Sarclisa Escena; Sanofi-Aventis U.S. LLC) across three indications for adults with multiple myeloma. The approval includes use in combination with pomalidomide and dexamethasone for patients who have received at least 1 prior line of therapy, including lenalidomide and a proteasome inhibitor; in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma after 1 to 3 prior lines of therapy; and in combination with bortezomib, lenalidomide, and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.

For the pomalidomide- and dexamethasone-based indication, efficacy was established in the phase 3 IRAKLIA trial, an open-label, randomized, noninferiority study that enrolled 531 patients who received either subcutaneous isatuximab administered with an on-body delivery system (OBDS) or intravenous isatuximab, each in combination with pomalidomide and dexamethasone. The primary efficacy end points were overall response rate (ORR), as assessed by an independent review committee, and steady-state trough concentration (Ctrough). The ORR was 71.1% with subcutaneous isatuximab and 70.5% with intravenous isatuximab. The geometric mean ratio for steady-state Ctrough was 1.53.

For the carfilzomib- and dexamethasone-based indication, efficacy was supported by the phase 2 IZALCO study of 74 patients with relapsed or refractory multiple myeloma. The IRC-assessed ORR was 79.7%.

For the newly diagnosed setting, efficacy was supported by the investigator-sponsored phase 2 IsaSocut study, which enrolled 74 patients with transplant-ineligible multiple myeloma. The ORR was 97.3%.

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

The recommended dose of subcutaneous isatuximab-irfc is 1,400 mg administered in combination with the approved treatment regimens.

Source: 

US Food and Drug Administration. FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications. Accessed July 10, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications