FDA approves under-the-skin option for multiple myeloma treatment

The U.S. Food and Drug Administration (FDA) has approved a new version of Sarclisa (isatuximab), an approved treatment for multiple myeloma sold by Sanofi.

The original version of Sarclisa is given intravenously, by infusion into a vein. The new version, called Sarclisa Escena, is given subcutaneously — by injection under the skin. Sarclisa Escena can be administered by manual injection using a traditional syringe or with an on-body injector (OBI), a device placed on the skin that delivers the therapy with the touch of a button. The OBI device used for Sarclisa Escena is known as the CirCLIQ OBI.

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According to Sanofi, Sarclisa Escena is the first anticancer treatment to be administered through an OBI, and the first multiple myeloma treatment available in the U.S. by both OBI and manual under-the-skin injection. The FDA approval comes about a month after the under-the-skin formulation was approved in the European Union.

“Sarclisa is the cornerstone of our oncology franchise, and we have always been confident in it being widely adopted as a potential best-in-class therapy,” Manuela Buxo, executive vice president, head of specialty care at Sanofi, said in a company press release. “The approval of Sarclisa Escena subcutaneous formulation administered with the CirCLIQ is a definitive step in this direction. More than 70,000 patients worldwide have benefitted from Sarclisa, delivering predictable and important efficacy and safety across multiple combinations and lines of therapy. Today, we are proud to bring innovation that will empower physicians to enhance the treatment experience for patients, offering greater simplicity, flexibility and convenience.”

Multiple myeloma is a blood cancer driven by the abnormal growth of plasma cells, immune cells found in the bone marrow. Sarclisa works to kill myeloma cells by targeting CD38, a protein expressed on the surface of the cancerous plasma cells. Both the original formulation and the new subcutaneous version are FDA-approved for use as part of several different treatment combinations. These include certain patients with newly diagnosed myeloma who are not eligible for a stem cell transplant, as well as patients whose myeloma has returned or not responded after prior treatments.

Trial supports injection version’s approval

FDA approval of the subcutaneous version was supported by multiple studies, including the Phase 3 IRAKLIA clinical trial (NCT05405166), which tested the OBI-administered subcutaneous formulation against the original intravenous formulation in adults with relapsed or refractory multiple myeloma. Results showed that both versions were comparable in their safety profiles and ability to elicit a treatment response.

“Multiple myeloma is a malignancy that often requires frequent [intravenous] infusions or manual subcutaneous injections. Treatment administration can be a cumbersome experience for patients, while also placing a strain on providers by requiring physical effort to push high-resistance syringes for several minutes,” said Sikander Ailawadhi, MD, a professor of medicine in the division of hematology/oncology at Mayo Clinic Florida and the principal investigator of the IRAKLIA study. “The comparable efficacy observed across multiple studies and the patient-centric design of the OBI offers an opportunity to impact the patient experience while upholding Sarclisa’s consistent efficacy.”

Donna D. Catamero, associate director of myeloma research and adjunct faculty at Mount Sinai Phillips School of Nursing, said the introduction of the therapy with the on-body injector “represents a significant advancement in multiple myeloma care.”

“For nurses and physicians treating patients with multiple myeloma, this automated system has the potential to meaningfully reduce administrative burden, simplifying how therapy is delivered and giving healthcare teams more capacity to focus on their patients,” Catamero said.