The drug also received orphan drug designation.
The FDA has approved isatuximab-irfc (Sarclisa, Sanofi-Aventis US LLC), in combination with pomalidomide and dexamethasone, for the treatment of adults with multiple myeloma (MM) who have received at least 2 prior therapies. The drug also received orphan drug designation.
Isatuximab-irfc is a CD38-directed cytolytic antibody that functions by helping certain cells in the immune system attack MM cancer cells. The targeted cell approach to treating MM has been instrumental in developing oncology treatments.
MM is a blood cancer that occurs in infection-fighting plasma cells found in the bone marrow. These cells multiply, produce an abnormal protein, and push out other healthy blood cells from the bone marrow. It results in a weakened immune system and causes other bone or kidney problems. According to the National Cancer Institute, there could be 32,270 new cases of MM and 12,830 related deaths in 2020.
The approval is based on the results of a clinical trial involving 307 patients with relapsed and refractory MM who had received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor. Half of the participants received isatuximab-irfc in combination with pomalidomide and low-dose dexamethasone, while the other half received only pomalidomide and low-dose dexamethasone. Efficacy was based on progression-free survival (PFS).
Patients who received isatuximab-irfc in combination with pomalidomide and low-dose dexamethasone showed improvement in PFS with a 40% reduction in the risk of disease progression or death compared with patients who did not receive isatuximab-irfc. These patients also had an overall response rate of 60.4%, compared with 35.5% in patients who did not receive isatuximab-irfc.
Common adverse effects of isatuximab-irfc included neutropenia, infusion-related reactions, pneumonia, upper respiratory tract infection, diarrhea, anemia, lymphopenia, and thrombocytopenia.
Blood banks should be informed that patients are receiving isatuximab-irfc because the drug may interact with some tests performed for patients who need a blood transfusion. Pregnant women should not use isatuximab-irfc.
FDA Approves New Therapy for Patients with Previously Treated Multiple Myeloma [news release]. White Oak, MD; March 2, 2020. FDA website, https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-patients-previously-treated-multiple-myeloma. Accessed March 2, 2020.