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Sanofi snags FDA thumbs up for Sarclisa as 1st cancer drug delivered by on-body injector

Published

10 July 2026

Topic

opportunities

Sectors

Digital Health

Geography

United States

Source

Read at fiercepharma.com

Verified

Fusion42 · 10 July 2026 · Fusion42 review

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.

This Wire brief sits within Fusion42's coverage of Digital Health.

◆ The Wire takeaway

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.

Coverage

1 source · 10 Jul 2026

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Topics

Digital Healthon-body-injectorsubcutaneous-deliverymultiple-myelomadevice-pharmaregulatory-approval