News|Articles|July 10, 2026

FDA Approves Sarclisa Escena as a New Under the Skin Treatment Option for Multiple Myeloma

Listen

0:00 / 0:00

Key Takeaways

Regulatory clearance adds a 1,400-mg subcutaneous CD38 antibody option using CirCLIQ on-body delivery or provider-administered injection, maintaining the same active medicine as the IV formulation.
IRAKLIA (>500 previously treated patients) showed noninferior clinical activity versus IV isatuximab with Pd, with ORR ~71% subcutaneous vs ~70% IV and comparable pharmacokinetics.
IZALCO supported use with Kd in relapsed/refractory disease, reporting an objective response rate near 80% in a heavily pretreated population.
IsaSocut evaluated frontline use in transplant-ineligible NDMM with VRd, yielding a 97.3% response rate, reinforcing feasibility of subcutaneous delivery in induction-style regimens.
Labeling highlights administration-related reactions, neutropenia and infection risk, second primary malignancies, assay interference (eg, serologic testing), and embryo-fetal toxicity requiring counseling and monitoring.

The FDA approved Sarclisa Escena, a new subcutaneous treatment option for adults with multiple myeloma across newly diagnosed and relapsed settings.

The Food and Drug Administration (FDA) has approved Sarclisa Escena (isatuximab-irfc) as a new under-the-skin (subcutaneous) injection for adults with multiple myeloma.

The approval gives patients and healthcare providers another way to receive Sarclisa, which was previously available only as an intravenous (IV) infusion. The new formulation can be given as an injection using the CirCLIQ On-Body Delivery System or by a healthcare provider using a syringe.

Sarclisa Escena is approved for use in three different treatment settings. It can be combined with Pomalyst (pomalidomide) and dexamethasone for patients whose multiple myeloma has returned after at least one previous treatment. It is also approved with Kyprolis (carfilzomib) and dexamethasone for patients whose disease has relapsed or become resistant to treatment after one to three prior therapies. In addition, it can be used with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone for people who are newly diagnosed with multiple myeloma and are not eligible for an autologous stem cell transplant.

How Sarclisa Works

Sarclisa is a type of targeted antibody therapy. It works by attaching to a protein called CD38 that is found on the surface of multiple myeloma cells. Once attached, it helps the body's immune system recognize and destroy those cancer cells.

The newly approved subcutaneous version delivers the same medicine as the IV formulation but offers another administration option for patients and their care teams.

What the Clinical Trials Found

The FDA based its decision on results from three clinical studies that evaluated subcutaneous Sarclisa in different groups of patients with multiple myeloma.

The largest study, called IRAKLIA, included more than 500 patients whose disease had already been treated. Researchers compared the new under-the-skin injection with the original IV version of Sarclisa, with both groups also receiving Pomalyst and dexamethasone.

The results showed that the two formulations worked similarly. About 71% of patients receiving the subcutaneous injection responded to treatment, compared with about 70% of those receiving the IV formulation. Researchers also found that the amount of medicine reaching the bloodstream was consistent with the IV version.

Another study, IZALCO, evaluated Sarclisa Escena in combination with Kyprolis and dexamethasone in patients with relapsed or refractory multiple myeloma. Nearly 80% of patients experienced a response to treatment.

A third study, IsaSocut, enrolled patients who were newly diagnosed with multiple myeloma and were not candidates for a stem cell transplant. When Sarclisa Escena was combined with Velcade, Revlimid and dexamethasone, 97.3% of patients responded to treatment.

While response rates do not necessarily mean a patient is cured or that treatment will work the same for everyone, they help researchers measure how well a therapy is controlling the disease.

How the Treatment Is Given

Sarclisa Escena is given as a 1,400-milligram injection under the skin. Depending on the treatment center, it may be administered using the CirCLIQ On-Body Delivery System or by manual injection from a healthcare provider. It is always given as part of a combination treatment regimen for multiple myeloma.

Side Effects and Safety

Like all cancer treatments, Sarclisa Escena can cause side effects. The prescribing information includes warnings about allergic or administration-related reactions, low white blood cell counts (called neutropenia), infections, the development of additional cancers, interference with certain laboratory tests and the potential to harm an unborn baby.

Patients should talk with their healthcare team about the potential benefits and risks of treatment and whether Sarclisa Escena is an appropriate option for their specific type and stage of multiple myeloma.