The US FDA has approved the subcutaneous formulation of isatuximab (Sarclisa Escena) in combination with standard-of-care regimens for the treatment of adult patients with multiple myeloma. Approved indications In combination with pomalidomide and dexamethasone for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor In combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy In combination with bortezomib, lenalidomide, and dexamethasone for patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant Clinical evidence In a clinical trial involving 531 patients, subcutaneous isatuximab combined with pomalidomide and dexamethasone achieved an objective response rate of 71.1%,โฆ
FDA Approves Subcutaneous Isatuximab for Multiple Myeloma