On March 2, the U.S. Food and Drug Administration (FDA) approved isatuximab-irfc (Sarclisa) in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Isatuximab-irfc, administered through intravenous infusion, is a CD38-directed cytolytic antibody that works by helping certain cells in the immune system attack multiple myeloma cancer cells.
“Targeting cells has led to the development of important oncology treatments. While there is no cure for multiple myeloma, isatuximab-irfc 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 Ating Director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “In the clinical trial, there was a 40% reduction in the risk of disease progression or death with this therapy.”
The FDA approved isatuximab-irfc based on the results of the phase III ICARIA-MM clinical trial, which involved 307 patients with relapsed and refractory multiple myeloma who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor. 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 efficacy of isatuximab-irfc was determined by progression-free survival. Patients who received isatuximab-irfc in combination with pomalidomide and low-dose dexamethasone showed improvement in progression-free survival, with a 40% reduction in the risk of disease progression or death compared to patients who received pomalidomide and dexamethasone (hazard ratio [HR] = 0.596, 95% confidence interval [CI] = 0.44–0.81, P = .0010). These patients also had an overall response rate of 60.4%. In comparison, the patients who only received pomalidomide and low-dose dexamethasone had an overall response rate of 35.3%.
Median progression-free survival for the patients who received the triplet therapy was 11.53 months (95% CI = 8.94–13.9) vs 6.47 months (95% CI = 4.47–8.28) for those who received only pomalidomide and low-dose dexamethasone.
The most common adverse reactions (≥ 20% of patients) were neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, and diarrhea.
The recommended isatuximab-irfc dose is 10 mg/kg as an intravenous infusion every week for 4 weeks followed by every 2 weeks in combination with pomalidomide and dexamethasone until disease progression or unacceptable toxicity.