The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc), in combination with pomalidomide and dexamethasone, to treat adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Isatuximab-irfc is a CD38-directed cytolytic antibody that is administered through intravenous infusion.
Multiple myeloma is a rare hematologic malignancy characterized by the expansion of malignant plasma cells in the bone marrow associated with excessive production of monoclonal immunoglobulins in blood and urine. Individuals with multiple myeloma develop significant osteolytic bone lesions and have immunodeficiency that compromise their longevity and quality of life. Numerous treatment options are available for multiple myeloma but relapse is common.
In a news release, Richard Pazdur, MD, of the FDA stated, “While there is no cure for multiple myeloma, Sarclisa is now another CD38-directed treatment option added to the list of FDA-approved treatments of patients with multiple myeloma who have progressive disease after previous therapies.”
The approval of isatuximab-irfc was largely based on results of a clinical trial involving 307 patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor. In the study, half the patients Half of the patients received isatuximab-irfc in combination with pomalidomide and low-dose dexamethasone and the other half received only pomalidomide and low-dose dexamethasone. The isatuximab-irfc group showed improvement in progressive-free survival with a 40% reduction in the risk of disease progression or death compared to the control group Furthermore, the overall response rate was 60.4% in the isatuximab-irfc group compared to 35.5% in the control group.
Common side effects reported for patients taking isatuximab-irfc were neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, diarrhea, anemia, lymphopenia and thrombocytopenia.
Isatuximab-irfc can cause serious infusion-related reactions and if person has such reaction, the drug should be permanently discontinued. Isatuximab-irfc can also cause neutropenia and may increase the risk of second primary malignancies.
