FDA Approves Sarclisa Escena (isatuximab-irfc) Subcutaneous for Multiple MyelomaFDA approves new multiple myeloma drug Sarclisa Escena for injection under the skin.

Sarclisa Escena is a CD38-directed cytolytic antibody.

Sarclisa Escena is indicated in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least 1 prior line of therapy including lenalidomide and a proteasome inhibitor. It is also indicated in combination with carfilzomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. Additionally, it is indicated in combination with bortezomib, lenalidomide, and dexamethasone for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).

Sarclisa Escena is for subcutaneous use only. The recommended dosage is 1,400 mg administered subcutaneously with the CirCLIQ On-Body Delivery System or with a syringe and infusion set for manual administration. Premedicate with dexamethasone, leukotriene receptor antagonist, acetaminophen, and diphenhydramine 15 to 60 minutes prior to administration. Dosing schedules vary by combination regimen: for pomalidomide/dexamethasone or carfilzomib/dexamethasone, weekly in cycle 1 then every 2 weeks; for bortezomib/lenalidomide/dexamethasone, weekly in cycle 1, every 2 weeks in cycles 2-12, then every 4 weeks from cycle 13 onward. Treatment continues until disease progression or unacceptable toxicity.

Trial data not available in label.

Not reported in label.

Sarclisa Escena provides a subcutaneous formulation of isatuximab-irfc for multiple myeloma, offering an alternative route of administration to intravenous isatuximab-irfc. It is used in combination with standard backbone therapies across different lines of treatment, including for newly diagnosed patients ineligible for transplant and for relapsed/refractory disease.