FDA Approves Isatuximab-irfc for Previously Treated Myeloma

The FDA approved isatuximab-irfc (Sarclisa) plus pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who had 2 or more prior therapies, including lenalidomide and a proteasome inhibitor.

The approval was based on the results of a clinical trial that involved 307 patients with relapsed and refractory myeloma who had at least 2 previous therapies, including lenalidomide and a proteasome inhibitor. The participants were broken up into 2 groups: 1 was given isatuximab-irfc plus pomalidomide and low-dose dexamethasone, while the other group was given just pomalidomide and low-dose dexamethasone.

Patients on the isatuximab-irfc arm had a 40% reduction in the risk of disease progression or death compared to the patients who did not receive the agent. Overall response rate was 60.4% and 35.5% in the 3-drug and 2-drug arms, respectively.

“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.

Isatuximab-irfc has some common adverse events (AEs) that oncology nurses should look out for, including infusion-related reactions. If a patient has a grade 3 or higher reaction, the drug should be stopped permanently. Other AEs include infection. neutropenia, pneumonia, upper respiratory tract infection, diarrhea, anemia, lymphopenia, and thrombocytopenia. There was a higher rate of secondary primary malignancies in patients given isatuximab-irfc.