Sanofi snags FDA thumbs up for Sarclisa as 1st cancer drug delivered…

Sanofi wins FDA approval for Sarclisa Escena, the first cancer drug deliverable by on-body injector, matching efficacy to its IV formulation and using Enable Injections' CirCLIQ device. The subcutaneous option positions Sarclisa to compete more directly with J&J's Darzalex Faspro in multiple myeloma treatment. If you make delivery devices for large-volume injectables, Sanofi just proved the on-body injector is now table-stakes for competing oncology drugs—and J&J's five-year head start on subcutaneous Darzalex is eroding. Enable Injections owns this FDA playbook; your window to license or co-develop a competing platform is closing fast.