US Approves First On-Body Injector Cancer Treatment for Multiple Myeloma

July 13, 2026
By Mintesinot Nigussie

The US Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Sarclisa (isatuximab-irfc) that allows patients with multiple myeloma to receive treatment through an automated on-body injector or manual injection, marking the first anticancer therapy approved for administration through both methods.

The approval expands the use of Sarclisa Escena, developed by Sanofi, across all existing indications of its intravenous formulation for multiple myeloma, a type of blood cancer that affects plasma cells.

The decision was supported by several studies, including the phase three IRAKLIA trial, which found that Sarclisa Escena delivered through an on-body injector achieved comparable efficacy, safety and pharmacokinetic outcomes to intravenous infusion, while reducing treatment time and lowering infusion-related reactions.

The trial involved patients with relapsed or refractory multiple myeloma who had received at least one previous line of treatment. Sarclisa Escena combined with pomalidomide and dexamethasone achieved an objective response rate of 71.1 percent, compared with 70.5 percent for the intravenous formulation combined with the same regimen, meeting the study’s non-inferiority criteria.

The study also found fewer systemic administration reactions among patients receiving the subcutaneous formulation. While 25 percent of patients receiving the intravenous treatment experienced such reactions, the rate was 1.5 percent among those treated through the on-body injector.

The treatment uses Enable Injections’ CirCLIQ on-body injector, developed through the enFuse platform, which delivers high-volume medicines under the skin with the push of a button. The device uses a retractable 30-gauge needle designed to reduce discomfort compared with commonly used needles for large-volume injections.

“Multiple myeloma is a malignancy that often requires frequent IV infusions or manual subcutaneous injections,” said Sikander Ailawadhi, professor of medicine at Mayo Clinic Florida and principal investigator of the IRAKLIA study. He said the comparable efficacy and patient-focused design of the injector could improve treatment experiences while maintaining Sarclisa’s established effectiveness.

Sanofi said more than 70,000 patients worldwide have received Sarclisa, adding that the new formulation could provide greater flexibility and convenience for patients while reducing administrative pressure on healthcare providers.

The company’s executive vice president and head of Specialty Care, Manuela Buxo, said the approval represents a step towards expanding the treatment’s adoption by giving physicians additional options for delivering therapy. Healthcare professionals also highlighted the potential operational benefits of the technology.

Donna D. Catamero, associate director of Myeloma Research at Mount Sinai Phillips School of Nursing, said the automated system could reduce administrative workload for nurses and physicians, allowing healthcare teams to spend more time with patients.

Sarclisa is currently approved in the US for three multiple myeloma indications, including use with bortezomib, lenalidomide and dexamethasone for newly diagnosed patients who are not eligible for autologous stem cell transplant. It is also approved for relapsed or refractory cases in combination with pomalidomide and dexamethasone, and with carfilzomib and dexamethasone.

Source: FSX Business News