FDA Approves Subcutaneous Sarclisa (Isatuximab-Irfc) for Multiple Myeloma Treatment

New formulation expands Sanofi’s Sarclisa portfolio by offering a subcutaneous delivery option across multiple myeloma treatment settings, including newly diagnosed, relapsed and refractory disease. The US Food and Drug Administration (FDA) has approved a subcutaneous formulation of isatuximab-irfc (Sarclisa Escena) for the treatment of adults with multiple myeloma across three approved treatment combinations. The approval provides patients and healthcare professionals with an alternative administration method to the existing intravenous formulation of the Sanofi-developed anti-CD38 monoclonal antibody.

The FDA decision was supported by clinical data demonstrating that subcutaneous isatuximab-irfc delivered comparable efficacy to intravenous administration, while offering the potential for a more convenient treatment experience through reduced administration burden.

Subcutaneous Sarclisa Matches Intravenous Efficacy in Phase III Study

The primary evidence supporting the FDA approval came from the Phase III IRAKLIA trial (NCT05405166), which evaluated whether subcutaneous administration could provide similar outcomes to the existing intravenous formulation.

The open-label, randomised non-inferiority study enrolled 531 patients with multiple myeloma, assigning participants to receive either subcutaneous isatuximab-irfc with an on-body delivery system or intravenous isatuximab-irfc, both alongside pomalidomide and dexamethasone.

The study met its key objectives:

• Overall response rate (ORR) was 71.1% in the subcutaneous treatment group compared with 70.5% in the intravenous group.

• Drug exposure levels were comparable, with steady-state trough concentrations favouring subcutaneous administration.
  

The results demonstrated that subcutaneous Sarclisa maintained the clinical activity of intravenous therapy while providing an alternative delivery option for patients.

Additional Clinical Data Support Broader Multiple Myeloma Use

The FDA approval was also supported by data from additional clinical studies evaluating subcutaneous isatuximab-irfc in different multiple myeloma populations.

In the Phase II IZALCO study (NCT05704049), subcutaneous Sarclisa was evaluated in combination with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma.

The study reported:

• Overall response rate of 79.7% based on independent review committee assessment.
  

The Phase II IsaSocut study (NCT05889221) evaluated subcutaneous isatuximab-irfc alongside bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients who were not eligible for stem cell transplantation.

The study demonstrated:

• Overall response rate of 97.3%.
  

Together, these results supported the use of subcutaneous Sarclisa across multiple stages of multiple myeloma treatment.

Addressing Treatment Burden in Multiple Myeloma Care

Multiple myeloma remains a complex blood cancer requiring long-term treatment approaches involving combinations of targeted therapies, immunomodulatory drugs and corticosteroids.

While anti-CD38 antibodies such as isatuximab-irfc have become important components of multiple myeloma treatment, intravenous administration can increase clinic time and place additional demands on healthcare systems.

The introduction of a subcutaneous formulation could help simplify treatment delivery by providing a potentially faster and more flexible administration approach.

The move also reflects a wider trend across oncology, where pharmaceutical companies are increasingly developing subcutaneous versions of established biologic therapies to improve patient convenience and optimise healthcare resource use.

Sarclisa Safety Profile Remains Consistent

The FDA prescribing information includes warnings and precautions relating to:

• Hypersensitivity and administration-related reactions

• Neutropenia

• Infections

• Secondary primary malignancies

• Laboratory test interference

• Embryo-fetal toxicity
  

Healthcare professionals are advised to monitor patients for potential adverse reactions during treatment.

What the FDA Approval Means for Multiple Myeloma Treatment

The approval of subcutaneous Sarclisa expands treatment options for patients with multiple myeloma by providing an alternative to intravenous administration without compromising clinical efficacy.

With positive results from the Phase III IRAKLIA study and supporting Phase II data across multiple treatment settings, Sanofi’s Sarclisa portfolio is positioned to play a broader role in the evolving multiple myeloma treatment landscape.

As oncology care continues to move towards more convenient and patient-centred delivery models, subcutaneous biologics are expected to become an increasingly important part of long-term cancer management.

Summary

The FDA has approved subcutaneous isatuximab-irfc (Sarclisa Escena) for adults with multiple myeloma across newly diagnosed, relapsed and refractory treatment settings.

The approval was supported by the Phase III IRAKLIA trial, which showed comparable efficacy between subcutaneous and intravenous administration, alongside additional Phase II studies demonstrating strong response rates in different patient populations.

The new formulation expands Sanofi’s multiple myeloma offering while supporting a broader shift towards more convenient cancer treatment delivery.

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