The FDA has approved a subcutaneous version of isatuximab (Sarclisa Escena, Sanofi-Aventis) for several multiple myeloma (MM) indications.

Sarclisa Escena can be administered with the hands-free automated CirCLIQ on-body injector (OBI), according to a press release from Sanofi.

The drug is “the first anticancer treatment to be administered through an OBI, and the first [multiple myeloma] treatment available by both [subcutaneous] OBI and manual [subcutaneous] administration in the US,” Sanofi said. Sarclisa Escena can now be used with OBI in combination with standard-of-care regimens for the treatment of patients with MM across all existing indications of the drug’s intravenous formulation.

According to an FDA statement, Sarclisa Escena is approved:

• In combination with pomalidomide and dexamethasone, for the treatment of adult patients with MM who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor
• In combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory MM who have received one to three prior lines of therapy
• In combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed MM who are not eligible for an autologous stem cell transplant.

The efficacy of isatuximab administered subcutaneously in combination with pomalidomide and dexamethasone was evaluated in an open-label, noninferiority trial called IRAKLIA (NCT05405166). It involved 531 patients who were randomly assigned (1:1) to receive either subcutaneous isatuximab administered with the OBI or intravenous isatuximab, in combination with pomalidomide and dexamethasone. The major outcome measures were overall response rate (ORR) and the pharmacokinetic endpoint of trough concentration (Ctrough) at steady state (corresponding to predose at cycle 6, day 1). The ORR was 71.1% in the subcutaneous arm and 70.5% in the intravenous arm. The subcutaneous/intravenous geometric mean ratio for observed steady-state Ctrough (predose at cycle 6, day 1) was 1.53.

The efficacy of isatuximab administered subcutaneously in combination with carfilzomib and dexamethasone was evaluated with ORR in the phase 2 IZALCO (NCT05704049) trial. The trial included 74 patients with relapsed and/or refractory MM, and the ORR was 79.7%.

The efficacy of isatuximab administered subcutaneously in combination with bortezomib, lenalidomide, and dexamethasone was also evaluated using the ORR in a single-arm, phase 2 clinical study called IsaSocut (NCT05889221). The study included 74 patients with newly diagnosed MM who were not eligible for stem cell transplantation. The ORR for this trial was 97.3%.

Prescribing information for Sarclisa Escena includes warnings and precautions for hypersensitivity and other administration reactions, neutropenia, infections, secondary primary malignancies, laboratory test interference, and embryo-fetal toxicity.

The recommended isatuximab dose is 1400 mg administered as a subcutaneous injection with the CirCLIQ OBI or with a syringe and infusion set for manual administration, in combination with the specified regimens.

Full prescribing information for Sarclisa Escena will be posted on Drugs@FDA.