A New Way to Receive Sarclisa (Isatuximab): What the Subcutaneous On-Body Delivery System Means for Patients

For patients with multiple myeloma, managing the disease often involves balancing effective treatment with the demands it places on their time, energy, and overall quality of life. That’s why today’s approval of subcutaneous (under-the-skin) delivery of Isatuximab-irfc (Sarclisa^®) using an on-body delivery system (OBDS) is a positive development for many patients and caregivers.

Subcutaneous Sarclisa is now approved for:

• For some patients whose myeloma has returned or stopped responding to treatment, in combination with pomalidomide (Pomalyst®) and dexamethasone after treatment with lenalidomide (Revlimid®) and a proteasome inhibitor, such as bortezomib (Velcade®) or carfilzomib (Kyprolis®).
• For patients with relapsed or refractory myeloma, in combination with carfilzomib (Kyprolis®) and dexamethasone after one to three prior lines of therapy.
• For certain patients with newly diagnosed myeloma who are not eligible for a stem cell transplant, in combination with bortezomib (Velcade®), lenalidomide (Revlimid®), and dexamethasone.

Here, the MMRF highlights what this news means and why it matters for patients.

A Different Way to Receive Treatment

Sarclisa is a CD38 monoclonal antibody that is given through an intravenous (IV) infusion, meaning the medication is delivered directly into a vein over several hours at a clinic or hospital. It is in the same class of treatments as Darzalex^® (daratumumab), and they are often used interchangeably.

With the new subcutaneous (SC) on-body delivery system, the medication is delivered just under the skin through a wearable device placed on the body, similar to how an insulin pump works.

This can mean:

• Shorter treatment times: SC on body delivery takes significantly less time than IV infusions, which can last several hours.
• Fixed dosing: Instead of dosing based on body weight, the SC version uses a fixed dose, simplifying preparation and administration.
• Smaller volume: The amount of fluid delivered is lower, which can make the experience more comfortable.
• Less time in the clinic: This can mean fewer disruptions to a patients’ day and more time spent at home or doing the things they enjoy.

For many patients, this shift could make treatment feel less burdensome and more manageable.

Does Subcutaneous On Body Delivery Work as Well as IV Infusion?

The answer comes from several clinical trials, including a phase 3 study known as IRAKLIA. This study was designed to test whether subcutaneous Sarclisa delivered through the on-body device worked just as well (non-inferior) as the traditional IV infusion (typically approved for newly diagnosed patients or those who have relapsed after at least two other therapies). Here were the top findings:

• The SC version performed just as effectively as the IV version in terms of the percentage of patients who responded to either treatment
• Overall side effects were comparable between SC and IV delivery.
• Some patients receiving SC treatment experienced more localized reactions at the injection site (such as redness or mild discomfort).
• On the other hand, infusion-related reactions, which are more common with IV treatments, may be reduced with SC delivery.

In short, the SC on body delivery option showed no difference in effectiveness versus the IV treatment.

What Did Patients Think?

For many patients, how a treatment fits into daily life is just as important as how well it works, and results from the phase 3 IRAKLIA study suggest that subcutaneous Sarclisa delivered via an on-body device is viewed positively.

In IRAKLIA, 70 percent of patients receiving subcutaneous Sarclisa were satisfied or very satisfied, compared with about 53 percent of those receiving IV treatment. In addition, quality-of-life findings indicated that patients treated with the on-body delivery system reported better overall quality of life than those receiving IV infusions.

These results suggest that subcutaneous Sarclisa may offer a more convenient and patient-friendly treatment experience, while maintaining the effectiveness of IV therapy.

Looking Forward

One of the exciting possibilities in this news is what this technology could mean for the future. Because the on-body delivery system is designed to be wearable and relatively simple to use, there is potential for at-home administration down the line. While this is not standard practice yet, it raises an important question:

Could patients one day receive their treatment in the comfort of their own home?

For now, treatment is still given under medical supervision, but this innovation opens the door to more flexible care models in the future.

What You Can Do Now

If you or a loved one are receiving Sarclisa, it may be worth talking to your healthcare team about whether this new option is appropriate for your treatment plan. Here are some helpful questions to ask:

• Is a subcutaneous, on-body delivery system an option for me?
• How would switching from IV to subcutaneous treatment change my time in the clinic and overall experience?
• What side effects should I expect with the subcutaneous option, and how do they compare to IV treatment?

In addition to your care team, the MMRF Patient Navigation Center can offer support in answering these questions and give one‑on‑one guidance tailored for you. The MMRF Education Hub also offers additional materials to help better understand treatment options and navigate you along your myeloma journey.