Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted a third indication for its CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). The new approval allows for the first-line use of Sarclisa in combination with standard-of-care treatments, specifically bortezomib, lenalidomide, and dexamethasone (VRd), for adult patients with newly diagnosed MM who are not eligible for transplant.
The FDA’s decision was supported by the positive results from the IMROZ Phase III study, which demonstrated that the combination of Sarclisa with VRd significantly improved progression-free survival (PFS) compared to VRd alone. The median PFS for the Sarclisa VRd combination was not reached at 59.7 months, compared to 54.3 months for VRd alone, indicating a 40% reduction in the risk of disease progression or death.
This latest indication follows Sanofi’s previous approvals for Sarclisa in the US, which included its initial approval in 2020 for use in combination with pomalidomide and dexamethasone (pom-dex) as a third-line MM treatment, and in 2021 for use with carfilzomib and dexamethasone (Kd) as a second-line MM treatment. While Sarclisa has not yet received approval in China, the drug is currently under review by the National Medical Products Administration. – Fineline.com
