The U.S. Food and Drug Administration has approved Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with relapsed refractory multiple myeloma (RRMM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is expected to be available to patients in the U.S. shortly. Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells.
According to Sanofi, the FDA approval of Sarclisa provides a new treatment option for patients with difficult-to-treat multiple myeloma. "These are patients whose disease has returned or become resistant to their prior treatments,” said Sanofi CEO Paul Hudson.
In the ICARIA-MM study, Sarclisa added to pom-dex (Sarclisa combination therapy) demonstrated a statistically significant improvement in progression free survival (PFS) with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone. Sarclisa combination therapy also demonstrated a significantly greater overall response rate compared to pom-dex alone.
Sarclisa is an intravenous (IV) administration and is dosed at 10 mg/kg, in combination with pom-dex, every week for four weeks and then every two weeks, until disease progression or unacceptable toxicity. The first cycle is administered in an infusion time of 200 minutes, which can decrease to 75 minutes for the third cycle onwards. A treatment cycle is 28 days.
The U.S. list price for Sarclisa is $650 per 100 mg vial and $3,250 per 500 mg vial.
Multiple myeloma is the second most common hematologic malignancy, affecting more than 130,000 patients in the United States and approximately 32,000 Americans are diagnosed with multiple myeloma each year.
Read the full Sanofi release