FDA approves Sanofi’s Sarclisa to treat relapsed multiple myeloma

The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy.

“In the Phase 3 IKEMA study, the addition of Sarclisa to carfilzomib and dexamethasone reduced risk of disease progression or death by 45%,” said Thomas G. Martin, M.D., Associate Director, Myeloma Program, The University of California, San Francisco, Professor of Medicine, Adult Leukemia and Bone Marrow Transplantation Program and co-leader of the Hematopoietic Malignancies Program, Helen Diller Family Comprehensive Cancer Center. “This approval is an important advancement for patients whose disease has relapsed and reinforces the potential for Sarclisa to become a standard of care in relapsed or refractory multiple myeloma.”

This marks the second FDA approval for Sarclisa, which is also approved in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, the company noted in its press release.

Peter C. Adamson, M.D., Global Development Head, Oncology and Pediatric Innovation at Sanofi said that this approval further supports Sanifi’s ambition for Sarclisa to become the anti-CD38 of choice for patients with relapsed or refractory multiple myeloma.”