Dr. Moreau on the FDA Approval of Isatuximab Plus Carfilzomib/Dexamethasone in Multiple Myeloma

Philippe Moreau, MD, professor of clinical hematology, Nantes Faculty of Medicine, head, Translational Research Program, University Hospital of Nantes, University of Nantes, France, discusses the FDA approval of isatuximab-irfc (Sarclisa) plus carfilzomib (Kyprolis) and dexamethasone (Kd) in relapsed/refractory multiple myeloma.

On March 31, 2021, the FDA approved isatuximab plus Kd for the treatment of patients with relapsed/refractory multiple myeloma who have previously received 1 to 3 prior lines of therapy. On April 19, 2021, the European Commission approved the combination for use in patients with relapsed multiple myeloma who received at least 1 prior therapy.

Both regulatory decisions were based on findings from the phase 3 IKEMA trial, which demonstrated a 45% reduction in the risk of disease progression or death with the triplet vs Kd alone in this patient population.

As such, isatuximab plus Kd could be considered a new standard of care option for patients in their first or second relapse, particularly for patients who are refractory to lenalidomide (Revlimid), concludes Moreau.