Sanofi’s Sarclisa subcutaneous receives EU approval as the first anticancer therapy delivered through an on-body injector

The European Commission has given its approval for Sarclisa (isatuximab) subcutaneous (SC), in combination with standard-of-care regimens, for patients living with multiple myeloma (MM) spanning all currently authorized indications for the Sarclisa intravenous (IV) formulation. Sarclisa becomes the first anticancer therapy within the EU to be delivered via an on-body injector (OBI) alongside manual SC administration, bringing with it the added benefit of treatment flexibility — whether at home or in a clinical outpatient setting.

“Multiple myeloma is a complex disease that often requires repeated and prolonged clinic visits, placing a considerable burden on patients and those who support them. There has been a need for innovative approaches to ease this aspect of the treatment journey,” said Mohamad Mohty, MD, PhD, Professor of Hematology at the Sorbonne University and Head of the Clinical Hematology and Cellular Therapy Department at the Saint-Antoine Hospital, Paris, France. “The ability to administer a therapy through an on-body injector, particularly an anti-CD38 monoclonal antibody with well-established efficacy, either in the clinic or at home represents a meaningful step forward. With this new option now approved, we have an opportunity to reduce pressure on healthcare systems while placing greater flexibility and convenience at the heart of patient-centered care.”

Having first entered the market in 2020, Sarclisa has since been prescribed to patients across the globe. The IV formulation carries authorization across four indications in the EU, among them use alongside bortezomib, lenalidomide, and dexamethasone in both transplant-ineligible and transplant-eligible newly diagnosed MM. For patients with relapsed and/or refractory (R/R) MM, authorization extends to combinations with pomalidomide and dexamethasone (Pd) or carfilzomib and dexamethasone. The SC approval, which follows a favorable opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use, is grounded in data from the pivotal IRAKLIA Phase 3 study in R/R MM, which confirmed the non-inferiority of the SC formulation relative to IV, along with a body of additional supporting evidence.

“Our approach to innovation in cancer care is grounded in real-world impact, both advancing treatment and improving how care is delivered,” said Olivier Nataf, Global Head of Oncology at Sanofi. “Sarclisa, which has been prescribed to nearly 70,000 patients worldwide, already brings a well-established safety and efficacy profile across the multiple myeloma care continuum. With today’s EU approval, we’re combining that foundation with the added convenience, flexibility, and accessibility of the CirCLIQ on-body injector, which could offer a meaningful difference in the treatment experience.”

Data emerging from both the IRAKLIA and IZALCO studies point to the OBI being associated with increased simplicity, flexibility, and patient satisfaction when placed alongside IV administration, with both patients and healthcare providers expressing a clear preference for the OBI over manual SC delivery. Within the IRAKLIA Phase 3 study, seven in ten patients receiving Sarclisa SC via an OBI described themselves as satisfied or very satisfied with the injection experience, against 53.4% among those on Sarclisa IV. The IZALCO Phase 2 study went further — having experienced both approaches firsthand, nearly three quarters of patients (74.5%) indicated a preference for the OBI method, while just 17% favored manual injection and 8.5% expressed no preference, underscoring a compelling pull toward the hands-free option.

Sarclisa is to be used alongside Enable Injections’ CirCLIQ® OBI, an automated delivery device built on the enFuse® platform, engineered to administer Sarclisa subcutaneously at the touch of a button across both home and outpatient environments. The device incorporates a concealed retractable needle, notably shorter and finer than those conventional to large-volume subcutaneous delivery.

In the IRAKLIA study — marking the first time an OBI has featured in a Phase 3 MM trial — Sarclisa SC via OBI paired with Pd produced an objective response rate (ORR) of 71.1%, set against 70.5% for Sarclisa IV-Pd, confirming non-inferiority among adult patients with R/R MM having completed at least one prior line of therapy.

The safety profile observed for Sarclisa SC-Pd aligned closely with what has previously been established for the IV-Pd combination. Systemic infusion reactions were recorded in a quarter of IV-Pd patients, dropping sharply to 1.5% among those in the SC-Pd arm. No previously unseen safety issues emerged, with the exception of mild, localized injection site reactions appearing in 0.4% of OBI administrations. The vast majority of these reactions were grade 1 in severity, with a single grade 2 episode recorded.

Among the most frequently occurring grade ≥3 nonhematologic adverse events were pneumonia (14.8% OBI vs. 15.5% IV), COVID-19 (2.7% vs. 1.9%), and upper respiratory tract infection (1.5% across both groups). On the hematologic side, grade ≥3 laboratory abnormalities most commonly included neutropenia (84.7% OBI vs. 74.3% IV), thrombocytopenia (26.1% vs. 23%), and anemia (17.6% vs. 19.5%).

Among patients in regions where home administration was permitted, median injection time via the OBI held steady at 13 minutes regardless of whether treatment took place at home or in a clinic. At-home delivery proved well tolerated, with no emerging safety concerns and every scheduled injection completed as planned.

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Related Topics and Keywords

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