The U.S. Food and Drug Administration (FDA) has approved Sanofi ’s subcutaneous Sarclisa Escena in combination with standard-of-care regimens for the treatment of patients with multiple myeloma across all existing indications of the intravenous formulation. This approval establishes Sarclisa Escena as the first anticancer treatment to be administered through both an on-body injector (OBI) and manual subcutaneous administration, offering a new option for patients and healthcare providers by significantly reducing treatment time and infusion-related reactions.

The FDA approval was supported by the pivotal IRAKLIA phase 3 non-inferiority study, which demonstrated that Sarclisa Escena administered subcutaneously via an OBI provided similar efficacy, pharmacokinetics, and safety compared to intravenous infusion. The IRAKLIA study was the first Phase 3 trial in multiple myeloma to incorporate an on-body injector.

Clinical Trial Results

In the IRAKLIA phase 3 study, Sarclisa subcutaneous administration via an OBI in combination with pomalidomide and dexamethasone resulted in an objective response rate (ORR) of 71.1% (187/263), compared to 70.5% (189/268) with intravenous Sarclisa. This established non-inferiority with a relative risk of 1.008 (95% confidence interval: 0.903-1.126) in adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

The overall safety profile was consistent with the established intravenous profile. Systemic administration reactions occurred in 25% of patients treated with intravenous Sarclisa, compared to 1.5% of patients treated with the subcutaneous formulation. Injection site reactions occurred in 0.4% of OBI injections (n=19/5,145 injections), with nearly all classified as grade 1.

Treatment Administration and Indications

The studies utilized Enable Injections’ hands-free OBI, the CirCLIQ, developed using the enFuse platform. The device delivers high-volume medicines subcutaneously with the push of a button and uses a retractable 30g needle, shorter and thinner than those commonly used for large-volume injections. This system aims to reduce the physical burden on nurses and provide more freedom for patient monitoring.

Sarclisa is currently approved across three indications in the US. These include combination with bortezomib, lenalidomide, and dexamethasone in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplant. In relapsed or refractory multiple myeloma, it is approved in combination with pomalidomide and dexamethasone for patients who have received at least two prior therapies, as well as in combination with carfilzomib and dexamethasone for patients who have received one to three prior lines of therapy.

"The approval of Sarclisa Escena subcutaneous formulation administered with the CirCLIQ is a definitive step in this direction," said Manuela Buxo, Executive Vice President, Head of Specialty Care at Sanofi. "More than 70,000 patients worldwide have benefitted from Sarclisa, delivering predictable and important efficacy and safety across multiple combinations and lines of therapy."

The European Commission is seeking feedback from the market on commitments offered by Sanofi regarding potential anticompetitive conduct involving the promotion of its flu vaccine for vulnerable patients. The initiative aims to address concerns over the company's promotional strategies that may have restricted competition in the market.

Background of the Case

The Commission's investigation centers on whether Sanofi engaged in practices that could be deemed anticompetitive, particularly in the promotion of its flu vaccine. The focus is on how these practices may have affected the market for vaccines intended for vulnerable patient groups.

Next Steps

Market participants and interested parties are invited to provide their comments on the commitments proposed by Sanofi. The feedback will be assessed by the Commission to determine if the commitments adequately address the competition concerns raised during the investigation.