FDA Approves Sarclisa Escena for Multiple Myeloma

On July 9, 2026, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa Escena, Sanofi) for subcutaneous (under-the-skin) injection for three approved multiple myeloma treatment combinations. The approval gives patients another way to receive isatuximab, a CD38-targeting antibody that was previously available only as an IV infusion.

Multiple myeloma is a blood cancer that begins in plasma cells. Although treatments have improved over the past decade, many people diagnosed with multiple myeloma may need additional therapies because the disease returns or stops responding to treatment. New options that maintain effectiveness while making treatment more convenient can help improve outcomes and patient experiences.

How does Sarclisa treat multiple myeloma? 

Isatuximab has been approved for multiple myeloma since 2020. This new approval introduces a subcutaneous formulation, called Sarclisa Escena, that can be given using an on-body delivery system or by manual injection. The new design allows for more flexibility for administration with the same clinical outcomes. 

Isatuximab-irfc contains a monoclonal antibody that targets CD38. CD38 is a protein found in high amounts on multiple myeloma cells. When isatuximab binds to CD38, it helps the immune system identify and target myeloma cells. 

Instead of through IV infusion, Isatuximab-irfc is administered as a 1,400 mg subcutaneous injection using an on-body delivery system or infusion. It follows the same treatment schedule as the IV formulation.

The FDA based this approval on several clinical studies evaluating the new subcutaneous formulation.

The largest study, IRAKLIA (NCT05405166), enrolled 531 patients with relapsed or refractory multiple myeloma receiving pomalidomide and dexamethasone. Researchers compared subcutaneous isatuximab with the standard IV formulation.

The overall response rate was:

• 71.1% with subcutaneous isatuximab
• 70.5% with IV isatuximab

The study also showed that the subcutaneous version performed similarly to the IV formulation.

Additional studies supported approval for other treatment combinations:

• IZALCO (74 patients): Isatuximab with carfilzomib and dexamethasone achieved an overall response rate of 79.7%. 
• IsaSocut (74 patients): Isatuximab with bortezomib, lenalidomide, and dexamethasone achieved an overall response rate of 97.3% newly diagnosed people who are not eligible for transplant.

Common side effects 

The prescribing information includes warnings for:

• Injection-site reactions 
• Low white blood cell counts (Neutropenia and leukopenia)
• Low platelet counts (thrombocytopenia)
• Anemia or low hemoglobin levels
• Respiratory tract infections
• Secondary primary cancers
• Alteration in laboratory tests 
• Embryo-fetal toxicity in pregnancy
• Fatigue and musculoskeletal pain
• Pneumonia 
• Gastrointestinal symptoms like diarrhea

The safety profile of the subcutaneous formulation was similar to that of the previously approved intravenous version of isatuximab.

Next steps 

If you have multiple myeloma, consider speaking with your healthcare team about whether a subcutaneous form of isatuximab could be right for you. While Sarclisa Escena contains the same active medicine as the IV formulation, receiving treatment under the skin may offer a more convenient option for some patients. Your doctor can help determine whether on body injection fits your current treatment goals.

Questions to ask your healthcare team 

• Am I eligible to receive the new subcutaneous version of isatuximab?
• How does the injection compare with the IV infusion in terms of effectiveness and safety?
• How long does the injection take compared with an infusion?
• Will switching to the subcutaneous formulation change my treatment schedule?
• What side effects should I watch for while receiving Sarclisa Escena?

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Sources: 

• FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications 
• Sanofi Press Release 
• HealthTree-A New Way to Administer Isatuximab (Sarclisa) That Reduces Side Effects