FDA Approves Sarclisa to Treat Multiple Myeloma

The Food and Drug Administration (FDA) approved the targeted drug Sarclisa (isatuximab-irfc) as part of a combination treatment for the blood cancer multiple myeloma.

Sarclisa was approved in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa, given through intravenous infusion, inhibits the activity of the protein CD38 to help certain cells in the immune system attack cancer cells.

Multiple myeloma occurs in the bone marrow, in white blood cells whose job is to fight infection. When the cancerous cells multiply, they produce an abnormal protein that pushes healthy blood cells out of the marrow, weakening a patient’s immune system.

Sarclisa received orphan drug designation, which provides its manufacturer incentives to assist and encourage the development of drugs for rare diseases.

“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 for patients with multiple myeloma who have progressive disease after previous therapies,” said Dr. Richard Pazdur, 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.

The FDA approved Sarclisa based on the results of a clinical trial involving 307 patients with recurrent or treatment-resistant myeloma who had taken at least two prior therapies, including lenalidomide and a proteasome inhibitor. Patients received pomalidomide and low-dose dexamethasone, either with or without Sarclisa.

The trial measured the progression-free survival associated with each of the two regimens, meaning the length of time a patient stayed alive without the cancer growing. Patients who received the regimen that included Sarclisa faced a 40% lower risk of disease progression or death compared with patients who received the two-drug regimen.

Common side effects for patients taking Sarclisa were drops in white blood cell or platelet levels, reactions at the infusion site, pneumonia, upper respiratory tract infections, diarrhea and anemia. Serious side effects can include new cancers, the FDA reported.

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