EU approves under-the-skin Sarclisa for multiple myeloma
New formulation can be given manually or with on-body injector
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The European Commission has approved a new subcutaneous (under-the-skin) formulation of Sarclisa (isatuximab), a treatment for multiple myeloma that was previously available in an intravenous (into-the-vein) formulation.
The new subcutaneous version can be administered manually using a traditional syringe or with an on-body injector (OBI), called the CirCLIQ OBI, which is placed on the skin and automatically injects the medication at the touch of a button.
The approval makes Sanofi‘s Sarclisa the first anticancer treatment in the European Union (EU) to be administered through an OBI, and the first multiple myeloma treatment available by both subcutaneous OBI and manual injection. The new formulation may offer more flexibility for administration in outpatient or home settings, where permitted. This contrasts with the original intravenous infusion, which usually needed to be administered at a clinic or infusion center.
Sarclisa injection may offer more flexibility
“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,” Olivier Nataf, global head of oncology at Sanofi, said in a company press release.
“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,” Nataf added.
The newly approved formulation covers the same four indications as the original intravenous formulation. This means it will be available in combination with other therapies for patients who have received previous lines of treatment, as well as for those who are newly diagnosed.
The U.S. Food and Drug Administration is also reviewing the subcutaneous formulation of Sarclisa, with a decision expected in July.
“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, head of the Clinical Hematology and Cellular Therapy Department at the Saint-Antoine Hospital in France.
“The ability to administer a therapy through an on-body injector … either in the clinic or at home represents a meaningful step forward,” Mohty said. “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.”
Studies supported Sarclisa approval
Multiple myeloma is a blood cancer caused by the uncontrolled growth of plasma cells, immune cells that produce antibodies to fight infections and other foreign substances. Sarclisa is an antibody-based therapy designed to destroy cancerous plasma cells by targeting the CD38 protein at their surface. It is indicated for use with other standard-of-care myeloma treatments.
Sanofi’s applications seeking the approval of subcutaneous Sarclisa were based mainly on data from a Phase 3 clinical study called IRAKLIA (NCT05405166), which directly compared the subcutaneous formulation administered with an OBI against the original intravenous version in adults with relapsed or refractory multiple myeloma who had received at least one prior line of treatment.
Results showed the subcutaneous formulation was noninferior to the intravenous version in terms of objective response rate, a measure of the proportion of patients who responded to treatment. Its overall safety profile was consistent with the intravenous formulation, with no new safety signals reported among patients who received it at home where that was permitted.
Data from IRAKLIA and a previous Phase 2 trial called IZALCO (NCT05704049) also suggested the OBI may offer greater simplicity, flexibility, convenience, and patient satisfaction than intravenous administration. In IRAKLIA, more patients reported being satisfied or very satisfied with OBI administration than with intravenous infusion. IZALCO data also showed that patients preferred OBI administration over manual subcutaneous injection.
