In a significant step toward improving cancer treatment delivery, the U.S. Food and Drug Administration has approved a wearable version of Sanofi’s blood cancer drug, Sarclisa. The new option offers patients with multiple myeloma a more convenient alternative to traditional intravenous infusions.
This marks the first cancer therapy approved for delivery through an on-body injector attached to the skin. The approval strengthens Sanofi’s position as its CEO Belén Garijo works to reduce reliance on its top-selling asthma drug, Dupixent.
Sarclisa is approved for treating multiple myeloma, a rare and aggressive blood cancer that begins in the bone marrow. The wearable injector allows subcutaneous dosing, which can significantly cut down the time patients spend in infusion centers and reduce pressure on oncology clinics and healthcare staff.
Traditional IV infusions of the drug can take up to 3 hours, while the wearable injector delivers treatment in a median time of 13 minutes, according to the company.
The intravenous version of Sarclisa was first approved in 2020 for certain patients with relapsed multiple myeloma. The latest approval now covers all existing U.S. indications for the IV form.
Sanofi has priced the on-body injector version at $8,796 per vial. In comparison, a single-dose IV vial ranges from $956.10 to $4,780.54.
Sarclisa is a targeted immunotherapy that works by binding to myeloma cells and helping the immune system attack them. It competes with Johnson & Johnson’s Darzalex in the same treatment space.
The FDA’s decision is based on a late-stage trial showing that the wearable form of Sarclisa is as effective as its IV counterpart.
The drug generated €588 million ($671.67 million) in sales in 2025, with analysts projecting €710 million in 2026.
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