The US Food and Drug Administration has approved subcutaneous isatuximab-irfc (Sarclisa Escena; Sanofi-Aventis U.S. LLC) for three indications in adult patients with multiple myeloma, according to a US Food and Drug Administration announcement.

The approved indications include use in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy that included lenalidomide and a proteasome inhibitor. The subcutaneous formulation is also approved in combination with carfilzomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy, and in combination with bortezomib, lenalidomide, and dexamethasone for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation.

The FDA reported efficacy findings from the IRAKLIA, IZALCO, and IsaSocut studies.

In the open-label, noninferiority IRAKLIA trial, researchers randomly assigned 531 patients to receive either subcutaneous isatuximab-irfc administered with an on-body delivery system or intravenous isatuximab-irfc, both in combination with pomalidomide and dexamethasone. The major outcome measure, overall response rate assessed by an independent review committee, was 71% in the subcutaneous group and 71% in the intravenous group.

The FDA evaluated efficacy in the phase 2 IZALCO study, which enrolled 74 patients with relapsed or refractory multiple myeloma who received subcutaneous isatuximab-irfc in combination with carfilzomib and dexamethasone. The overall response rate, as assessed by an independent review committee, was 80%.

The FDA evaluated efficacy in the investigator-sponsored, single-arm phase 2 IsaSocut study, which enrolled 74 patients with newly diagnosed multiple myeloma who were not eligible for stem cell transplantation. Patients received subcutaneous isatuximab-irfc in combination with bortezomib, lenalidomide, and dexamethasone, and the overall response rate was 97%.

The prescribing information includes warnings and precautions regarding hypersensitivity and other administration reactions, neutropenia, infections, secondary primary malignancies, laboratory test interference, and embryo-fetal toxicity.

The recommended dose is 1,400 mg administered subcutaneously using the CirCLIQ on-body delivery system or by manual administration with a syringe and infusion set in combination with the specified regimens.

Source: US Food and Drug Administration