Sanofi plc (NYSE: SNY), a leading pharmaceutical company based in France, has announced that the U.S. Food and Drug Administration (FDA) has granted priority review status to a supplemental approval filing for its drug Sarclisa (isatuximab). The priority status is in recognition of the molecule’s potential use in treating adult patients with newly diagnosed, transplant-ineligible multiple myeloma (MM).
Sarclisa, a CD38 antibody, has already received two indication approvals in the U.S. It was approved for use in combination with pomalidomide and dexamethasone (pom-dex) for third-line or later relapsed/refractory MM in 2020, and in combination with carfilzomib and dexamethasone for fourth-line or later MM in 2021.
The latest filing is supported by data from the Phase III IMROZ study, which evaluated Sarclisa in combination with the standard-of-care regimen comprising bortezomib, lenalidomide, and dexamethasone (VRd). As reported in December 2023, the study achieved a planned interim analysis for efficacy, showing a statistically significant improvement in progression-free survival (PFS) with Sarclisa combined with VRd compared to VRd alone in transplant-ineligible patients with MM.- Flcube.com
