FDA Approves Sarclisa® for Previously Treated Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has granted approval to Sanofi-Aventis U.S. LLC for Sarclisa® (isatuximab-irfc), to be used in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma. It is indicated for patients who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor.^1-3

Proteasome inhibitors are protein complexes that help get rid of unneeded or damaged proteins. Sarclisa is a CD-38 directed cytolytic antibody. It works by getting cells in the immune system to attack the multiple myeloma cancer cells.^1-3

What is multiple myeloma?

Multiple myeloma is a cancer that starts in plasma cells. These are the white blood cells that produce antibodies. There is no known cause or cure. Multiple myeloma is characterized by a buildup of abnormal plasma cells in the bone marrow that form tumors in the bones. When there is an increase in the production of antibodies the result can be a thickening of the blood. This can prevent bone marrow from producing enough healthy blood cells.

How does Sarclisa work?

Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells.³ It is administered as an intravenous (IV) infusion. It is given in combination with dexamethasone, a corticosteroid and pomalidomide, a drug that suppresses the immune system and helps the body fight cancer, infection, or other diseases. This means it helps bone marrow produce normal blood cells and improves the ability of immune cells to kill the abnormal cells in the bone marrow.^1-5

Sarclisa is an example of new cancer treatments being developed that can target cells according to Richard Pazdur, MD, 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.^1-2

Sarclisa in clinical trials

FDA approval was based on the results of a Phase III clinical trial of 307 adults with relapsed and refractory multiple myeloma. Trial participants were given either Sarclisa in combination with pomalidomide and low-dose dexamethasone or only pomalidomide and low-dose dexamethasone. The trial measured the overall efficacy of Sarclisa based on the amount of time a patient stays alive without the cancer growing. This is called progression-free survival (PFS).^1-3

Findings demonstrated a 40 percent reduction in the risk of disease progression or death compared to those who received pomalidomide and dexamethasone alone. This resulted in a response rate of 60.4 percent compared to an overall 35.3 percent response rate for those who did not get Sarclisa ^1-3

Sarclisa was granted status as an Orphan Drug, which means it treats rare diseases.^1-3

What are the possible side effects of Sarclisa?

According to the FDA, the most common side effects of Sarclisa are:^1-3

• Neutropenia (low neutrophil count)
• Infusion-related reactions
• Pneumonia
• Upper respiratory infections
• Diarrhea
• Anemia (low red blood cell count)
• Lymphopenia (low white blood cell count)
• Thrombocytopenia (low platelet count)

More serious side effects can include:^1-3

• Severe IV related reactions that require discontinuation and medical management
• Increase in second primary cancers of the same organ or in a new area of the body

This is not a complete list of all possible side effects of Sarclisa. When starting any new drug, make sure to discuss with your doctor all drugs (prescription and over the counter), supplements and vitamins you take.^1-2

Important things to know about Sarclisa

Sarclisa is expected to be available in the U.S. soon.³

People taking Sarclisa should be monitored for changes in complete blood counts.^1-2 As part of the treatment, your healthcare team should monitor for signs of infection and the development of new malignancies. Sarclisa may also interfere with certain lab tests. The FDA recommends blood banks and labs be informed about patients receiving Sarclisa due to its potential impact on lab results.^1-2

Women who are pregnant or breastfeeding should not take Sarclisa. Effective contraception should be used by women of reproductive age while being treated with Sarclisa. Contraception should be continued for at least 5 months after treatment.^1-2