The US Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) for certain adults with relapsed refractory multiple myeloma (RRMM). The drug, in combination with pomalidomide and dexamethasone (pom-dex) is indicated for patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
The FDA says that the decision was made after the drug significantly reduced the risk of disease progression or death by 40% compared to pom-dex alone in a pivotal trial.
The approval of the monoclonal antibody “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 Paul Hudson, chief executive officer, Sanofi.
He continued, “At Sanofi, we are focused on discovering and developing medicines that may change the practice of medicine, and Sarclisa offers a potential new standard of care in the United States. We continue to evaluate Sarclisa in a comprehensive clinical program in multiple myeloma, as well as in other blood cancers and solid tumours.”
The drug in question works by binding to the CD38 receptor on multiple myeloma cells, and is designed to induce programmed tumour cell death (apoptosis) and immunomodulatory activity.
Multiple myeloma is the second most common blood cancer, affecting more than 130,000 patients in the US. Despite available treatments, multiple myeloma remains an incurable malignancy, and is associated with significant patient burden.
