FDA Approves Isatuximab On-Body Injector for Multiple Myeloma, Raising Anti-CD38 Competition
The U.S. Food and Drug Administration approved Sarclisa Escena, a subcutaneous formulation of isatuximab delivered via an automated on-body injector, for treating multiple myeloma on June 21. According to FDA officials, this marks the first anticancer therapy approved for delivery through an on-body injector, providing a new device-based option for patients with newly diagnosed and relapsed or refractory multiple myeloma.
The FDA’s approval of Sarclisa Escena covers all existing indications of the intravenous (IV) formulation of isatuximab-irfc for both newly diagnosed and relapsed or refractory multiple myeloma, officials said. This approval establishes a new drug-device combination approach in oncology by integrating a monoclonal antibody with a wearable injector platform.
The subcutaneous formulation is delivered via an automated on-body injector (OBI), marking the first anticancer therapy to receive FDA approval through this delivery mechanism, according to regulatory documents and Sanofi reports.
Sarclisa Escena is an anti-CD38 antibody specifically formulated for on-body injector delivery rather than IV infusion, records show. The product name distinguishes the new subcutaneous OBI formulation from the original IV isatuximab-irfc. The FDA’s decision positions Sarclisa Escena as a formally approved subcutaneous, device-based delivery option for adult multiple myeloma patients, covering both first-line and later-line treatment settings.
The approval aligns with the indications already held by IV Sarclisa. The IV formulation is approved for relapsed or refractory multiple myeloma in adults in combination with pomalidomide and dexamethasone after at least two prior therapies, including lenalidomide and a proteasome inhibitor, according to FDA labeling and clinical trial data. It is also approved in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplant (ASCT), based on results from the phase 3 IMROZ study. The OBI formulation enables subcutaneous delivery for these same indications, Sanofi confirmed.
Isatuximab-irfc is a CD38-directed cytolytic monoclonal antibody used in multiple myeloma treatment. Clinical trials have demonstrated significant benefits: in relapsed or refractory disease, the ICARIA-MM trial showed that Sarclisa plus pomalidomide and dexamethasone reduced the risk of disease progression or death by 40% compared to pomalidomide and dexamethasone alone (hazard ratio 0.596, 95% confidence interval 0.44–0.81, p=0.0010). In newly diagnosed, non-transplant-eligible patients, the IMROZ trial reported a 40% reduction in the risk of recurrence or death with Sarclisa combined with VRd followed by Sarclisa-Rd compared to VRd followed by Rd (hazard ratio 0.60, 95% confidence interval 0.44–0.81, p=0.0009). These efficacy data support the use of isatuximab across multiple disease stages, according to clinical investigators and regulatory filings.
The original IV Sarclisa is administered at a recommended dose of 10 mg/kg actual body weight. For relapsed or refractory multiple myeloma, the dosing schedule is weekly for four weeks, then every two weeks in 28-day cycles until disease progression or unacceptable toxicity. In newly diagnosed patients, the IV infusion is integrated into the VRd regimen at the same dose. The OBI approval introduces subcutaneous delivery via an automated on-body injector, replacing the need for traditional IV infusion sessions. While specific dosing frequency and injector programming details are included in the device-drug labeling, these have not been fully detailed in the available FDA summary.
The approval of Sarclisa Escena’s OBI formulation positions Sanofi to compete more directly with Johnson & Johnson’s daratumumab (Darzalex Faspro), which already offers a subcutaneous anti-CD38 option for multiple myeloma. Darzalex Faspro is an injectable subcutaneous form of daratumumab combined with hyaluronidase and is approved with VRd for transplant-eligible newly diagnosed patients, among other indications. Both isatuximab and daratumumab target CD38 on myeloma cells, placing them within the same therapeutic class and creating direct market and clinical competition, according to industry analysts and company statements. Prior to the OBI approval, daratumumab’s subcutaneous formulation had a convenience advantage over IV isatuximab; the new Sarclisa Escena OBI narrows this gap by offering a wearable, automated delivery option.
The Sarclisa Escena OBI approval creates a new on-body injector–based oncology product category, potentially influencing future drug-device combination strategies in cancer care, experts said. By covering all existing IV indications, the OBI formulation can be used across multiple lines of therapy, enhancing its adoption potential in clinical practice. The approval is expected to improve treatment convenience by reducing reliance on infusion center time, which may impact health-system workflow and resource use.
Multiple myeloma treatment now features two major anti-CD38 agents with advanced non-IV delivery options, intensifying differentiation based on administration routes, label breadth, and clinical outcomes, according to market reports. The FDA’s June 21 decision is viewed by Sanofi as a strategic milestone in the myeloma market and in device-enabled biologic delivery.
Isatuximab was first approved by the FDA in 2020 for relapsed or refractory multiple myeloma, with subsequent approvals expanding its use in newly diagnosed patients. The introduction of the on-body injector format represents an evolution in administration methods, complementing the established efficacy and safety profile of the drug. Further details on clinical utilization and real-world adoption are expected as the product becomes available in oncology practice.
