TUESDAY, March 3, 2020 (HealthDay News) -- Sarclisa (isatuximab-irfc) has been approved for the treatment of adults with multiple myeloma in combination with pomalidomide and dexamethasone, the U.S. Food and Drug Administration announced Monday.
Sarclisa, in combination with pomalidomide and dexamethasone, is indicated for patients who have previously received two therapies, including lenalidomide and a proteasome inhibitor. Sarclisa, a CD38-directed cytolytic antibody, is administered through intravenous infusion and helps certain cells in the immune system attack multiple myeloma cancer cells.
Approval of Sarclisa was based on clinical trial data from 307 patients with relapsed and refractory multiple myeloma who had received at least two prior therapies. Half of the patients were assigned to treatment with Sarclisa in combination with pomalidomide and low-dose dexamethasone; the other half received pomalidomide and low-dose dexamethasone alone. Compared with patients who received only pomalidomide and dexamethasone, those who also received Sarclisa had a 40 percent reduction in the risk for disease progression or death. Overall response was 60.4 percent in patients who received Sarclisa combined with pomalidomide and dexamethasone compared with 35.3 percent for those who received only pomalidomide and dexamethasone.
The most commonly reported side effects of Sarclisa include neutropenia, infusion-related reactions, pneumonia, upper respiratory infection, diarrhea, anemia, lymphopenia, and thrombocytopenia. Potential serious side effects of Sarclisa include intravenous infusion-related reactions, neutropenia, and second primary malignancies.
Approval was granted to Sanofi-Aventis U.S. LLC.