Sanofi Wins FDA Nod for Combo Therapy in Multiple Myeloma

Xconomy National — 

The FDA on Monday approved a Sanofi antibody drug for adults with multiple myeloma whose disease hasn’t responded to at least two prior therapies, including the chemotherapy lenalidomide and a proteasome inhibitor.

The drug, isatuximab-irfc (Sarclisa), was OK’d for patients in combination with pomalidomide, a chemotherapy, and dexamethasone, a corticosteroid (pom-dex). The Sanofi (NYSE: SNY) drug, which patients receive intravenously, is designed to target CD38, a protein that is widely expressed on multiple myeloma cells.

Findings from a Phase 3 trial of the isatuximab combination therapy showed the risk of disease progression or death was reduced by 40 percent compared to patients who received pom-dex alone. For patients on the combo, the median length of time before the disease worsened was 11.53 months; for those who received pom-dex alone, the median was 6.47 months. For those who received the combination, the overall response rate was 60.4 percent, compared to 35.3 percent for patients who received only pom-dex. The trial enrolled 307 patients.

Although there are treatments for multiple myeloma, the disease—the second most common form of blood cancer, after non-Hodgkin lymphoma—typically returns. About 32,000 people in the US will be diagnosed with the disease this year, and about 13,000 patients with the disease will die, according to the American Cancer Society.

The recommended dose of isatuximab is 10 mg/kg weekly for four weeks, then every two weeks in combination with pom-dex until the disease worsens or the side effects are no longer manageable.

Paris-based Sanofi set the list price at $650 per 100 mg vial and $3,250 per 500 mg vial, or about $5,200 per infusion for a typical US patient. The company says it expects the treatment to be available to patients in the US “shortly.”

The drug label warns that serious side effects of the drug may include IV infusion-related reactions, and neutropenia, or an abnormally low count of white blood cells called neutrophils, which increases a patient’s vulnerability to infection. Clinicians should monitor patients’ blood cell count during treatment, and watch those with neutropenia for signs of infection, the label says. Health care professionals should also look for any new cancer, as higher incidences of a secondary primary cancer were observed in a clinical trial of the drug.

In addition to those side effects, others considered common in those taking the drug are pneumonia, upper respiratory tract infection, and diarrhea.

Sanofi is also studying the drug in Phase 3 trials for people with relapsed/refractory or newly diagnosed multiple myeloma, and evaluating it as a treatment for other blood cancer types and solid tumors.

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