Sanofi's Sarclisa Gets FDA Nod for Expanded Use in Multiple Myeloma

Sanofi (SNY) announced that the FDA has approved the label expansion for the use of its multiple myeloma (MM) drug, Sarclisa (isatuximab). With this nod, Sarclisa is now approved in combination with Velcade (bortezomib), Bristol Myers' (BMY) Revlimid (lenalidomide) and dexamethasone (VRd) for the treatment of patients with newly diagnosed MM (NDMM) who are not eligible forautologous stem cell transplant (ASCT). The FDA's approval is based on data from the phase III IMROZ study, which evaluated Sarclisa plus ...