Sanofi has received approval from the U.S. Food and Drug Administration for Sarclisa Escena, a subcutaneous formulation of its multiple myeloma treatment Sarclisa. The approval covers all indications currently authorized for the drug’s intravenous formulation in the United States.
The newly approved version becomes the first subcutaneous anticancer treatment that can be administered either manually or through an on-body injector (OBI). It is also the first cancer drug approved by the FDA that can be delivered through an on-body injector attached to the skin. The treatment is approved for patients with multiple myeloma, a blood cancer that begins in the bone marrow.
The FDA’s decision was supported by data from several studies, including the phase 3 Iraklia trial. According to Sanofi, Iraklia was the first study to use an on-body injector for dosing patients with multiple myeloma. The trial found that the subcutaneous formulation reduced treatment time while demonstrating efficacy and safety results similar to those seen with the intravenous version of the drug.
In the study, Sarclisa Escena administered through an on-body injector in combination with Bristol Myers Squibb’s Pomalyst and the corticosteroid dexamethasone achieved an objective response rate of 71.1%. The intravenous Sarclisa regimen combined with the same medicines produced an objective response rate of 70.5%. The results established non-inferiority in adults with relapsed or refractory multiple myeloma who had received at least one prior line of treatment.
Sarclisa Escena is delivered using Enable Injections’ CirCLIQ hands-free automated device. The Cincinnati-based company previously received FDA approval for its enFuse on-body injector, which is used to administer Apellis Pharmaceuticals’ drug Empaveli. Sanofi said the CirCLIQ device uses a retractable 30-gauge needle that is shorter and thinner than needles commonly used for large-volume injections.
“Introduction of the OBI option represents a significant advancement in multiple myeloma care,” said Donna Catamero, Associate Director of Myeloma Research at Mount Sinai Phillips School of Nursing. Catamero also said the automated system has the potential to reduce administrative burden associated with treatment delivery and provide healthcare teams with additional capacity to focus on patients.
Sanofi has previously stated that intravenous administration of Sarclisa can take up to three hours, while the median injection time using the wearable device is 13 minutes. The intravenous version of the drug first received FDA approval in 2020 for certain patients with relapsed multiple myeloma.
The approval follows a three-month extension of the FDA review process. A decision had originally been expected by April 22 before the agency delayed its action date. In June, European regulators also approved subcutaneous Sarclisa, making it the first anticancer therapy in the European Union that can be administered through an on-body injector.
Sarclisa competes with Johnson & Johnson’s Darzalex in the anti-CD38 class of multiple myeloma treatments. Darzalex entered the market in 2015 and received approval for its subcutaneous formulation, Darzalex Faspro, in 2020. In 2025, Darzalex recorded sales of $14.4 billion, while Sanofi reported Sarclisa sales of €588 million. Sarclisa is approved in three indications, including first-line treatment for patients who are not eligible for stem cell transplantation, as well as approved uses in combination with Pomalyst and dexamethasone and with Amgen’s Kyprolis and dexamethasone.
Sarclisa has achieved a significant regulatory milestone after the U.S. Food and Drug Administration (FDA) approved its subcutaneous formulation for the treatment of eligible patients with multiple myeloma. The approval provides a more convenient method of administration while maintaining the therapeutic benefits of Sarclisa, supporting improved treatment experiences for both patients and healthcare providers.
FDA Approves Subcutaneous Formulation
The FDA approval allows Sarclisa to be administered as a subcutaneous injection rather than through the traditional intravenous infusion. This new formulation is expected to reduce treatment administration time and improve efficiency in clinical settings.
The approval demonstrates continued progress in developing patient-friendly cancer therapies without compromising effectiveness or safety.
Sarclisa Receives FDA Approval for Subcutaneous Use
With FDA approval secured, Sarclisa is expected to play an even greater role in the management of multiple myeloma. Ongoing clinical research may explore additional treatment combinations, expanded indications, and further improvements in patient care.
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