Dr. Baljevic on the FDA Approval of the ICARIA-MM Regimen in Relapsed/Refractory Multiple Myeloma

Muhamed Baljevic, MD, assistant professor, Department of Internal Medicine, Division of Oncology and Hematology, College of Medicine, University of Nebraska Medical Center, discusses the FDA approval of isatuximab-irfc (Sarclisa) in combination with pomalidomide (Pomalyst) and low-dose dexamethasone in relapsed/refractory multiple myeloma.

In March 2020, the FDA approved isatuximab in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with multiple myeloma who received at least 2 prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor. The regulatory decision was based on findings from the phase 3 ICARIA-MM trial (NCT02990338), in which the triplet regimen led to a 40% reduction in the risk of disease progression or death compared with pomalidomide and dexamethasone alone in this patient population.

The approval was significant in that it introduced a novel CD38-directed monoclonal antibody beyond daratumumab (Darzalex) to the paradigm and combined it with pomalidomide, a novel immunomodulatory agent, Baljevic says. The triplet fulfills a significant unmet need for patients with relapsed/refractory multiple myeloma who meet the specific prior therapy requirements needed to receive the regimen, Baljevic concludes.