The FDA has approved Sarclisa (isatuximab-irfc), 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. Sarclisa, administered through intravenous (IV) 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, 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, M.D., 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 the clinical trial, there was a 40% reduction in the risk of disease progression or death with this therapy.”
Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, produce an abnormal protein and push out other healthy blood cells from the bone marrow. The disease may result in a weakened immune system and cause other bone or kidney problems. The National Cancer Institute estimates there would be 32,270 new cases of multiple myeloma and 12,830 related deaths in the United States in 2020.
The FDA approved Sarclisa based on the results of a clinical trial involving 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 Sarclisa in combination with pomalidomide and low-dose dexamethasone and the other half received only pomalidomide and low-dose dexamethasone. The efficacy of Sarclisa was based on progression-free survival (PFS) – the amount of time a patient stays alive without the cancer growing. Patients who received Sarclisa 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 to patients who received pomalidomide and dexamethasone. 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%.
Common side effects for patients taking Sarclisa were neutropenia (abnormally low levels of white blood cells), infusion-related reactions, pneumonia (infection of the air sacs in one or both of the lungs), upper respiratory tract infection, diarrhea, anemia, lymphopenia (decrease in the level of white blood cells) and thrombocytopenia (abnormally low levels of platelets).
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