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.

The FDA’s April 23, 2026, Prescription Drug User Fee Act (PDUFA) date for subcutaneous isatuximab in relapsed/refractory multiple myeloma follows Sanofi’s announcement of positive phase 3 IRAKLIA study results, officials said. The IRAKLIA trial (NCT05405166) is the first global phase 3 study evaluating a subcutaneous cancer treatment administered via an on-body delivery system (OBDS), according to Sanofi. It enrolled 531 patients across 252 global sites with relapsed/refractory multiple myeloma, randomized equally to receive either subcutaneous Sarclisa plus pomalidomide and dexamethasone (Pd) or intravenous Sarclisa plus Pd in 28-day cycles.

The co-primary endpoints of the study were met, demonstrating non-inferior objective response rate (ORR) and trough concentration (Ctrough) at steady state for the subcutaneous formulation compared to intravenous administration, Sanofi officials confirmed.

The subcutaneous arm received a fixed 1,400 mg dose weekly for four weeks, then every two weeks, while the intravenous arm was dosed by weight on the same schedule, records show. Patients enrolled had received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor, and treatment continued until disease progression, unacceptable adverse events, or discontinuation. Sanofi announced these results on January 9, 2025.

The subcutaneous formulation aims to enhance patient experience by providing a more convenient administration route than intravenous infusion, according to company statements. The OBDS delivers the drug over a short period, reducing clinic time and potentially improving patient comfort. A survey of 12 nurses with experience using the OBDS in related trials found that 75% had direct experience with the device, and all agreed it facilitated a positive patient treatment experience. The survey, conducted among nurses involved in the GMMG-HD8 trials (NCT05804032), reported that the OBDS reduced clinic time by 60% compared to manual subcutaneous injection using a syringe, improved patient comfort by 50%, and reduced patient anxiety by 50%, according to the survey results.

Supporting data from the IZALCO phase 2 study (NCT05704049) further reinforce the potential benefits of subcutaneous isatuximab. The open-label, sequential design study involved 42 patients receiving manual subcutaneous injections via syringe and butterfly set, and 24 patients administered the drug using an on-body injector in the periumbilical region. Patients received a flat 1,400 mg subcutaneous dose of isatuximab combined with carfilzomib and dexamethasone. Carfilzomib dosing started at 20 mg/m² on days 1 and 2, escalating to 56 mg/m² on days 8, 9, 15, and 16 of cycle one, with similar dosing in subsequent cycles. Dexamethasone was administered at 20 mg intravenously or orally on specified days. The median time to first response was 1.05 months (95% CI, 0.986–1.216), and the median time to best response was 3.81 months (95% CI, 2.825–4.632). Median progression-free survival (PFS) was not reached at the time of reporting, with a 95% confidence interval of 13.14 months to not reached, indicating immature data, according to the study published in Blood Cancer Journal.

The FDA granted approval for isatuximab-irfc (Sarclisa) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma patients ineligible for autologous stem cell transplant on September 20, 2024. This approval was based in part on the IMROZ trial (NCT03319667), which randomized 446 patients aged 80 or younger in a 3:2 ratio to receive isatuximab plus VRd or VRd alone. The IMROZ trial reported a median PFS not reached for the isatuximab arm compared to 54.3 months for the control arm, with a hazard ratio of 0.60, according to trial records.

Additional ongoing trials include a high-risk smoldering multiple myeloma study (NCT04270409) evaluating isatuximab combined with lenalidomide and dexamethasone, and the GMMG-HD8 trial (NCT05804032), which is assessing subcutaneous isatuximab in newly diagnosed multiple myeloma patients. These studies aim to further define the role of subcutaneous isatuximab in various treatment settings.

Sanofi’s development of the subcutaneous formulation through the IRAKLIA and IZALCO studies is part of a broader effort to improve access to care and patient convenience in multiple myeloma treatment, according to company officials. The OBDS represents a novel delivery mechanism intended to reduce infusion-related burdens and clinic time, with ongoing nurse feedback and patient experience data supporting its use.

The FDA’s setting of the PDUFA date for subcutaneous isatuximab signals regulatory progress toward expanding treatment options for relapsed/refractory multiple myeloma. The approval decision will follow a comprehensive review of the IRAKLIA phase 3 data and associated safety and efficacy results, officials said.