Sanofi Says US FDA Approves Subcutaneous Sarclisa for Multiple Myeloma

Sanofi (SNY) said Friday the US Food and Drug Administration has approved subcutaneous Sarclisa Escena combined with standard-of-care regimens to treat multiple myeloma across all existing indications for the intravenous formulation. Sarclisa may now be delivered via both manual subcutaneous injection and the CirCLIQ on-body injector, the company said. The approval was supported by the results of a pivotal phase 3 non-inferiority trial, which showed the subcutaneous formulation administered through an OBI matched the intravenous version in efficacy, pharmacokinetics and safety, while reducing treatment time and infusion-related reactions. Sanofi said Sarclisa Escena is the first anticancer treatment approved for administration through an on-body injector in the US.