First-line Isatuximab-irfc With VRd Approved for Multiple Myeloma
The CD38-targeted antibody was approved for patients who are ineligible for stem cell transplant.
The U.S. Food and Drug Administration (FDA) has approved isatuximab-irfc (Sarclisa) in combination with VRd (a regimen consisting of bortezomib [Velclade], lenalidomide [Revlimid], and dexamethasone) for the first-line treatment of multiple myeloma in patients who are not eligible for a stem cell transplant.
Isatuximab-irfc is a monoclonal antibody that attaches to the CD38 protein expressed at abnormally high levels on multiple myeloma cells. Engagement of isatuximab-irfc with CD38 kills multiple myeloma cells in several ways, including by activating the immune system. VRd is a standard-of-care regimen for newly diagnosed, transplant-ineligible multiple myeloma and treats the disease by blocking critical cellular processes and inducing cell death.
Isatuximab-irfc was previously approved for patients whose multiple myeloma did not respond to or returned after previous treatments. The latest approval makes isatuximab-irfc available to patients who have not yet undergone any treatments for their multiple myeloma.
The approval was based on results from the open-label, randomized, active-controlled, phase III IMROZ clinical trial, which enrolled 446 patients with newly diagnosed multiple myeloma who were not eligible to undergo a stem cell transplant. Patients were randomly assigned (3:2) to receive either isatuximab-irfc plus VRd or VRd alone.
Compared with patients who received VRd alone, those who also received isatuximab-irfc were 40% less likely to have experienced disease progression or death within 60 months of starting treatment. At 60 months, the percentage of patients who remained free of disease progression was 63.2% in the isatuximab-irfc arm and 45.2% in the VRd only arm.
The recommended dose for isatuximab-irfc is 10 mg per every kilogram of body weight.
Multiple myeloma is a cancer in which abnormal white blood cells accumulate in the bone marrow and prevent the bone marrow from producing healthy blood cells. While stem cell transplants (also called bone marrow transplants) can be effective against multiple myeloma, many patients are not eligible for this intensive procedure due to their age or physical fitness. According to federal statistics, it was estimated that 35,780 individuals would be diagnosed with multiple myeloma and 12,540 patients would die of the disease in the United States in 2024.
The FDA rendered its decision on September 20, 2024.
