FDA Approves First On-Body Injector for Multiple Myeloma Treatment

The US Food and Drug Administration (FDA) approved subcutaneous (SC) isatuximab-irfc (Sarclisa Escena) in combination with standard-of-care regimens for patients with multiple myeloma (MM). This landmark approval covers all existing indications of the intravenous (IV) formulation, making it the first anticancer treatment administered via an on-body injector (OBI) and the first MM therapy available through both OBI and manual SC administration.

The approval is supported by the pivotal phase 3 IRAKLIA study, which demonstrated that SC isatuximab-irfc administered via the CirCLIQ OBI provided similar efficacy and safety to IV infusion. Specifically, the SC-pomalidomide/dexamethasone (Pd) arm showed a 71.1% objective response rate, compared to 70.5% for IV-Pd. Notably, systemic administration reactions were significantly lower with the OBI (1.5%) than with IV infusion (25%).

Sikander Ailawadhi, MD, Professor of Medicine at Mayo Clinic Florida and principal investigator of the IRAKLIA study, emphasized in an interview with Oncology Nursing News that this technology shifts the nursing paradigm away from routine IV or manual subcutaneous injections.

Unlike manual syringes that require physical effort to push for several minutes, the OBI is a hands-free, automated device.

“The nurse is not sitting there injecting anything. The nurse could be charting, they could be taking care of something else. If they are split between patients, they could be addressing the needs of a different patient,” Ailawadhi said regarding the 12-to-14-minute delivery time.

A transformative aspect of this approval for oncology departments is "point of care readiness," which simplifies the preparation process. Ailawadhi explained that “we may not even need the pharmacy to prepare the drug and send it. This is a vial that comes with the device. The vial can be loaded onto the device by the nurse at bedside and then that device can be taken out, has an adhesive, put onto the patient, press a button and that's it.”

Safety and reliability were also central to the device's clinical evaluation. The CirCLIQ OBI, developed using the enFuse platform, utilizes a retractable needle shorter and thinner than those used in standard large-volume injections. Ailawadhi noted that because the needle remains hidden, “there is no exposed needle when you take it out and put it on a patient. When you take it off from the patient, there is no exposed needle ever.” This design is “safer from that standpoint, with less concern of on the job injuries.”

According to Ailawadhi, clinical trial feedback from nursing staff has been “overwhelmingly positive,” as the automated system allows providers more freedom for patient monitoring and interaction. This shift toward a patient-centric, automated experience represents a significant advancement in the management of multiple myeloma.