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Approval of isatuximab-irfc (Sarclisa) was based on the results of a 307-person trial, according to a statement from the FDA.
The US Food and Drug Administration (FDA) has approved isatuximab-irfc (Sarclisa) in combination with pomalidomide and dexamethasone, for the treatment of multiple myeloma in adults patients who have received at least 2 prior therapies.
According to a statement from the FDA, the intravenous infusion from Sanofi-Aventis US was approved based on the results of a clinical trial in patients with relapsed and refractory multiple myeloma who received at least 2 prior therapies including lenalidomide and a proteasome inhibitor.
"Targeting cells has led to the development of important oncology treatments. 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," said Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research, in a statement.
The 307-person trial used to support the approval of isatuximab-irfc, which is a CD38-directed cytolytic antibody that works by helping certain cells in the immune system attack multiple myeloma cancer cells, highlighted the therapy’s ability to achieve progression-free survival (PFS). During the trial, patients receiving isatuximab-irfc displayed a 40% reduction Ibn risk of disease progression or death compared to patient who received pomalidomide and dexamethasone, according to the statement from the FDA.
Side effects common among patients taking isatuximab-irfc including neutropenia, pneumonia, upper respiratory tract infection, diarrhea, anemia, lymphopenia, and thrombocytopenia. The FDA’s statement also noted use of isatuximab-irfc is associated with an increase of serious side effects, including IV infusion-related reactions and higher incidences of second primary malignancies.