Sarclisa (isatuximab-irfc) is a CD38-directed cytolytic antibody.
Sarclisa is specifically indicated, 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 is supplied as a solution for intravenous infusion.
Administer the following pre-medications prior to Sarclisa infusion to reduce the risk and severity of infusion-related reactions. Administer the recommended pre-medication agents 15 to 60 minutes prior to starting a Sarclisa infusion.
Sarclisa should be administered by a healthcare professional, with immediate access to emergency equipment and appropriate medical support to manage infusion-related reactions if they occur. The recommended dose of Sarclisa is 10 mg/kg actual body weight administered as an intravenous infusion in combination with pomalidomide and dexamethasone, according to the following schedule:
Each treatment cycle consists of a 28-day period. Treatment is repeated until disease progression or unacceptable toxicity.
The FDA approval of Sarclisa was based on data from the Phase 3 trial, ICARIA-MM. The multicenter, multinational, randomized, open-label, 2-arm trial enrolled 307 patients with RRMM. The trial was designed to demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone. In the 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 (60.4% vs. 35.3%).
Adverse effects associated with the use of Sarclisa may include, but are not limited to, the following:
Sarclisa is a monoclonal antibody (mAb) that binds to the CD38 receptor on multiple myeloma cells. It is designed to induce programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on multiple myeloma cells and cell surface receptors.
For additional information regarding Sarclisa or relapsed refractory multiple myeloma, please visit Sanofi's web page.