FDA Approves Time-Saving Under-the-Skin Sarclisa for Multiple Myeloma

Written by Ted Samson

Posted on July 27, 2026

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Key Takeaways

The FDA has approved Sarclisa Escena, a new under-the-skin form of isatuximab-irfc, for certain adults with multiple myeloma, offering a faster alternative to the traditional IV infusion.

The U.S. Food and Drug Administration (FDA) has approved a new under-the-skin form of isatuximab-irfc called Sarclisa Escena, given either as a shot or through a hands-free injector, for certain adults with multiple myeloma. The approval gives people a faster way to receive a medicine that was previously given through an intravenous (IV) infusion and required a trip to an infusion center.

For people living with multiple myeloma, treatment may involve regular, lengthy visits to a clinic or infusion center. The under-the-skin option may be given at a doctor’s office, and time needed to receive treatment can be a matter of minutes instead of over an hour. It also can reduce some reactions related to IV administration for some people, such as chills, breathing problems, nausea, or blood pressure changes.

Still, the best treatment and delivery method will depend on each person’s health, treatment history, and preferences.

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What Is Sarclisa?

Sarclisa is the brand name for isatuximab-irfc. It is a type of medicine called a monoclonal antibody. The drug targets a protein called CD38, which is commonly found in high amounts on multiple myeloma cells. By attaching to CD38, the drug helps the immune system recognize and destroy myeloma cells.

Sarclisa isn’t used by itself. It’s combined with other multiple myeloma treatments, depending on factors including a person’s diagnosis and response to other treatments.

How Is Sarclisa Given?

Sarclisa has traditionally been given through an IV infusion. With an infusion, the medicine slowly enters the bloodstream through a vein while the person is monitored by their healthcare team.

Sarclisa Escena is injected into the tissue under the skin. It can be given in two ways:

A healthcare professional can give it manually using a syringe and infusion set.
It can be delivered through the CirCLIQ on-body delivery system.

An on-body injector is a small device that a healthcare professional places on the skin. Once activated, the device automatically delivers the medicine under the skin.

The system is hands-free and uses a retractable needle. It is designed to deliver a larger volume of medicine without requiring a nurse or another healthcare professional to continuously press a syringe for several minutes.

How Does Under-the-Skin Sarclisa Compare With IV Sarclisa?

The FDA based the approval in part on the phase 3 IRAKLIA clinical trial. The study included 531 adults with multiple myeloma who’d received previous treatment.

Everyone in the study received Sarclisa with pomalidomide and dexamethasone. Half received Sarclisa under the skin with the on-body injector, and half received it through an IV infusion. Researchers wanted to determine whether the under-the-skin version worked at least as well as the IV version.

Similar Response Rates

The overall response rate was:

71.1 percent among people who received under-the-skin Sarclisa
70.5 percent among people who received IV Sarclisa

The overall response rate is the percentage of people whose cancer became smaller or showed another defined response to treatment. The findings showed that the under-the-skin method produced a response rate similar to that of IV Sarclisa.

Previous phase 2 trials also found high response rates with under-the-skin Sarclisa in both relapsed or refractory and newly diagnosed multiple myeloma.

Faster Administration Time

The under-the-skin method also requires significantly less administration time than an IV infusion:

Getting the drug injected takes about six minutes.
Having the medicine delivered through the on-body injector usually takes about 20 minutes, but it may take up to 60 minutes if the medicine flows more slowly.
An IV infusion can take over three hours for the first infusion, about two hours for the second, and about 75 minutes for later infusions.

What Are the Possible Side Effects?

Like other cancer treatments, Sarclisa Escena can cause side effects. Side effects may vary depending on which medicines are used with the treatment.

The most common side effects listed in the prescribing information include:

Upper respiratory tract infections
Fatigue
Pneumonia
Muscle, bone, or joint pain
Diarrhea
Peripheral neuropathy (numbness or tingling)
Constipation
Injection-site reactions (redness or discoloration, pain, or swelling where the shot is given)
Trouble sleeping
Swelling
Rash
Skin redness or discoloration

Common blood test changes include lower levels of platelets, hemoglobin, and certain white blood cells. These white blood cells include neutrophils, which help fight infection, and lymphocytes, which play a role in the immune system.

Sarclisa Escena may also cause serious reactions during or after the injection, low neutrophil levels, infections, and second cancers. It may interfere with some blood and multiple myeloma monitoring tests and can harm a developing fetus.

Because Sarclisa Escena is injected under the skin, injection-site reactions may occur. People receiving treatment should tell their healthcare team about any new or worsening symptoms.

Why This Approval Matters

Multiple myeloma treatment often continues over many cycles and may require frequent appointments. The time, travel, and physical demands involved can affect daily life for people with myeloma and their caregivers.

The approval of under-the-skin Sarclisa doesn’t introduce a new active drug. Instead, it offers another way to receive an established treatment. Clinical trial results suggest that this approach provides a response rate similar to IV Sarclisa, while potentially reducing the time needed to receive each dose and lowering the chance of systemic (whole-body) reactions related to treatment administration.

Not every treatment works equally well for everyone. If you’re not getting the results you’d hoped for, are experiencing difficult side effects, or find your treatment schedule hard to manage, consider speaking with your healthcare team. They can review your personal response, overall health, treatment goals, and available options before deciding whether any change to the treatment plan is appropriate.

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