FDA Approves Sanofi Sarclisa for Relapsed Refractory Multiple Myeloma
The U.S. Food and Drug Administration has authorized Sanofi’s Sarclisa for adults with multiple myeloma who have received at least two prior therapies.
The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Sarclisa (isatuximab-irfc) for use in combination with pomalidomide and dexamethasone. The drug is indicated for patients with relapsed refractory multiple myeloma (RRMM) who have previously undergone at least two lines of treatment, including lenalidomide and a proteasome inhibitor.
The regulatory approval is supported by the Phase 3 ICARIA-MM trial, which evaluated the efficacy of the drug against a control group. Results showed that patients receiving the Sarclisa combination experienced a 40% reduction in the risk of disease progression or death compared to those receiving only pomalidomide and dexamethasone. Median progression-free survival improved from 6.47 months to 11.53 months.
As a monoclonal antibody, Sarclisa targets the CD38 receptor on myeloma cells. Clinical data indicated that common adverse reactions included neutropenia, infusion-related reactions, and respiratory tract infections. Sanofi plans to make the treatment available in the U.S. market immediately.