Sanofi wins FDA nod for subcutaneous Sarclisa with on-body injector

The FDA approved Sanofi’s Sarclisa Escena, a subcutaneous version of Sarclisa that can be delivered by hand or Enable Injections’ CirCLIQ on-body injector, marking the first subcutaneous anticancer therapy usable with an OBI. In a phase 3 trial in relapsed/refractory multiple myeloma after at least one prior line, Sarclisa Escena plus pomalidomide and dexamethasone achieved an objective response rate of 71.1%—non-inferior to 70.5% with the IV Sarclisa–pomalidomide–dexamethasone regimen—while reducing administration time. The device’s rollout positions Sanofi to better compete with Johnson & Johnson’s Darzalex Faspro. Europe had already cleared OBIs for Sarclisa, and J&J highlighted Darzalex’ broader indications and established, monthly dosing in its own subcutaneous form.