The US Food and Drug Administration (FDA) has approved Sanofi’s subcutaneous formulation of Sarclisa (isatuximab-irfc) Escena for the treatment of Multiple Myeloma (MM) across all existing indications currently approved for the intravenous (IV) formulation.

With this approval, Sarclisa Escena became the first anticancer therapy that can be administered using both an On-Body Injector (OBI) and manual subcutaneous (SC) injection. The approval covers its use in combination with standard-of-care regimens for patients with multiple myeloma.

The FDA's decision was supported by data from multiple clinical studies, including the pivotal phase 3 IRAKLIA trial, which demonstrated that subcutaneous administration via an on-body injector achieved efficacy, pharmacokinetics and safety comparable to the intravenous formulation. The study also showed significantly shorter treatment administration times and fewer infusion-related reactions.

The clinical programme utilised Enable Injections’ CirCLIQ on-body injector, developed on the company's enFuse platform. The hands-free device delivers high-volume medicines subcutaneously at the push of a button using a retractable 30-gauge needle, designed to improve patient comfort and simplify treatment administration.

Sarclisa is currently approved in the US for three multiple myeloma indications, including newly diagnosed patients who are not eligible for autologous stem cell transplant, as well as relapsed or refractory multiple myeloma in combination with approved treatment regimens following prior lines of therapy.

The approval expands treatment administration options for patients and healthcare providers while maintaining the established clinical profile of Sarclisa.