Sanofi: Sarclisa Becomes the First Cancer Drug Administered via Auto-Injector in the EU
The European Commission approved on Monday the subcutaneous formulation of Sarclisa (isatuximab), a treatment for multiple myeloma by Sanofi. This approval is a first: Sarclisa becomes the first cancer drug to be administered via a portable auto-injector in the European Union, offering patients the flexibility of home or outpatient treatment.
First European Cancer Drug Administered via Auto-Injector
Sarclisa in its subcutaneous formulation has received European approval in combination with standard therapeutic regimens for all types of multiple myeloma currently approved in intravenous form. The laboratory emphasizes that Sarclisa is the first European cancer drug to be administered via a portable auto-injector (OBI, on-body injector) and the first myeloma treatment to be offered in a subcutaneous version by manual injection and auto-injector in the European Union. This approval covers all existing indications of the treatment in its intravenous version: in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma (in both transplant-ineligible and eligible patients), as well as in combination with pomalidomide and dexamethasone or with carfilzomib and dexamethasone in relapsed or refractory myeloma.
High Satisfaction and Strong Preference for the Auto-Injector
The approval is based on the results of the pivotal phase 3 IRAKLIA study conducted in patients with relapsed or refractory myeloma, which demonstrated the non-inferiority of the subcutaneous formulation compared to the intravenous version. In this study, 70% of patients treated with subcutaneous Sarclisa via the auto-injector reported being satisfied or very satisfied with their injection, compared to 53.4% of patients receiving the intravenous version. The phase 2 IZALCO study further supports this finding: after experiencing both modes of administration, 74.5% of patients preferred Sarclisa administered subcutaneously via auto-injector over manual injection, while 17% preferred manual injection and 8.5% had no preference. The data suggest that the portable auto-injector could offer greater simplicity, flexibility, convenience, and patient satisfaction compared to intravenous administration, as well as a preference among patients and healthcare professionals over manual subcutaneous injection.
