On-Body Injector for Sanofi’s Isatuximab Approved by FDA, Upping Anti-CD38 Competition in Myeloma

FDA has approved an on-body injector for Sanofi’s anti-CD38 isatuximab, launching a new phase of competition in anti-CD38 regimens in multiple myeloma. Sanofi announced the approval, which applies to all existing formulations of isatuximab’s intravenous (IV) formulation.¹

The product, to be called Sanofi Escena, will be the first anticancer treatment with approval for administration through both an on-body injector (OBI) and manual subcutaneous (SC) administration. However, studies have shown that the OBI method offers safety advantages and is preferred by nurses, who do not have to manually administer the injection.

For years, isatuximab saw rival anti-CD38 therapy daratumumab gain market share with the introduction of its subcutaneous formulation (Darzalex Faspro; Johnson & Johnson). Experts have told The American Journal of Managed Care® that they anticipate approval of a subcutaneous option for isatuximab to revive discussion about the relative advantages of the 2 therapies.

In its statement, Sanofi said, “Sarclisa Escena administered via the CirCLIQ OBI offers the potential to change the overall patient experience,” in multiple myeloma treatment. “The hands-free automated injector may also streamline the administration process for providers by potentially reducing the physical burden on nurses and providing more freedom for patient monitoring and interaction.”

The approval is supported by the phase 3 IRAKLIA noninferiority study (NCT05405166), which showed that OBI administration offered similar efficacy, pharmacokinetics, and safety compared to IV infusion, as well as much shorter treatment time and fewer infusion-related reactions.

The OBI device was developed by Enable Injections, which has developed injection devices in other conditions; in 2023, its Empaveli with pegcetacoplan for paroxysmal nocturnal hemoglobinuria saw 90% of new patients opt for this delivery method in 4 months.

Having isatuximab available with an on-body injector “represents a significant advancement in multiple myeloma care,” said Donna D. Catamero, ANP-BC, OCN, CCRC, associate director, Myeloma Research; adjunct faculty for Mount Sinai Phillips School of Nursing and International Myeloma Foundation Nurse Leadership Board member. “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.”

In IRAKLIA, which was the first phase 3 study to use OBI in the treatment of myeloma, the use of OBI isatuximab with pomalidomide and dexamethasone (Isa-Pd) brought a 71.1% objective response rate, compared with 70.5% for IV Isa-Pd, establishing noninferiority (relative risk 1.008; 95% confidence interval: 0.903-1.126), in adult patients with relapsed or refractory MM (R/R MM) who have received at least 1 prior line of treatment.

The overall safety profile of the OBI combination was consistent with the established safety profile of the IV combination. While 25% of patients in the IV group experienced systemic administration reactions, only 1.5% of patients in the OBI group experienced those reactions. No new safety concerns were observed, except for injection site reactions (ISRs) that were seen in 0.4% of OBI injections (n=19/5,145 injections). Nearly all injection site reactions were grade 1; one reaction was grade 2.