The U.S. Food and Drug Administration (FDA) has approved a wearable version of Sanofi’s blood cancer drug Sarclisa, marking the first FDA-approved cancer treatment that can be administered through an on-body injector attached to the skin. The new device offers patients with multiple myeloma, a rare and aggressive blood cancer that begins in the bone marrow, a more convenient alternative to lengthy intravenous infusions.
The wearable injector significantly reduces treatment time, with a median injection duration of just 13 minutes compared to intravenous infusions that can take up to three hours. The approval applies to all existing U.S. indications previously covered by the intravenous version of Sarclisa, which was first approved in 2020 for certain patients with relapsed multiple myeloma. The decision was based on a late-stage clinical trial demonstrating that the wearable form was as effective as the intravenous treatment.
Sarclisa is a targeted immunotherapy that helps the immune system identify and attack myeloma cells and competes with Johnson & Johnson’s Darzalex in the anti-CD38 multiple myeloma treatment market. The approval represents a significant milestone for Sanofi as it seeks to strengthen its oncology portfolio. The drug generated €588 million in sales in 2025, with analysts projecting revenues of approximately €710 million in 2026.
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