A European Medicines Agency (EMA) panel has recommended approval of a subcutaneous (under-the-skin) version of Sarclisa (isatuximab), an approved myeloma treatment sold by Sanofi.
The recommendation, from the EMA’s Committee for Medicinal Products for Human Use (CHMP), suggests that the subcutaneous version should be approved for the same indications as the original formulation of Sarclisa, which is administered by infusion into the bloodstream. The European Commission, which has final say over drug approvals in the European Union, will review the recommendation. The commission isn’t obligated to abide by the CHMP’s recommendation, but it almost always does.
“This positive CHMP opinion is a pivotal milestone in our mission to improve the treatment experience for multiple myeloma patients and providers,” Olivier Nataf, global head of oncology at Sanofi, said in a company press release.
The subcutaneous version of Sarclisa is designed to be given either by manual injection (a traditional syringe using a plunger) or on-body injector (OBI), a device placed on the skin to administer the therapy at the press of a button. Sanofi said that if the subcutaneous formulation is approved, Sarclisa would become the first anticancer medicine administered using an OBI in the EU.
The OBI device used in clinical testing, called enFuse and sold by Enable Injections, uses a smaller needle than is typically used to administer large-volume injections like Sarclisa, according to Sanofi. The company said this type of injection may help make treatment more comfortable for patients.
“Our aim is to evolve the treatment experience by combining the clinically proven efficacy of Sarclisa with innovative subcutaneous delivery via an on-body injector,” Nataf said. “This advancement reflects our unwavering commitment to patients and dedication to transforming care in ways that truly matter to people living with cancer.”
Trial data show new formulation comparable to infusion version
Myeloma is a blood cancer caused by the uncontrolled growth of plasma cells, a type of immune cell. Sarclisa is a CD38 inhibitor, a type of myeloma immunotherapy that targets the CD38 protein expressed by cancer cells. The original formulation of Sarclisa is approved in the EU for use in various regimens for both newly diagnosed and previously treated myeloma, and is under review by the U.S. Food and Drug Administration.
The CHMP’s positive opinion on subcutaneous Sarclisa was based mainly on data from a Phase 3 clinical trial called IRAKLIA (NCT05405166), which compared the subcutaneous formulation with the original infusion formulation and showed the two were comparable in terms of efficacy and pharmacological properties.
The CHMP’s opinion also included data from four other clinical studies using subcutaneous Sarclisa: two in newly diagnosed patients (NCT05804032, NCT05889221) and two in relapsed/refractory patients whose cancer had failed to respond or relapsed following prior treatments (NCT05704049, NCT04045795).
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