USFDA Approves First Wearable Cancer Drug Delivery System for Sanofi's Sarclisa
London: The U.S. Food and Drug Administration said on Friday it has approved a wearable form of Sanofi's blood cancer drug, Sarclisa, offering multiple myeloma patients a less burdensome alternative to intravenous infusions.
It is the first cancer drug approved by the FDA that can be delivered through an on-body injector, attached to the skin.
The approval boosts the French drugmaker as new CEO Belen Garijo seeks to address investor concerns about reliance on asthma drug Dupixent, its biggest-selling medicine.
The new form of the drug is approved for patients with multiple myeloma - a rare and aggressive blood cancer that starts in the bone marrow.
Subcutaneous dosing can significantly reduce time spent in infusion centers for patients who receive repeated treatment courses, while also easing the strain on oncology clinics and nurses.
The infusions can take up to three hours, while the median injection time for the wearable device is 13 minutes, Sanofi has previously said.
An intravenous form of the drug first won FDA approval in 2020 for some patients with relapsed multiple myeloma. The fresh approval covers all existing U.S. indications for the IV form.
The U.S. list price for the drug with the on-body injector is $8,796 per vial, Sanofi said. A single-dose vial of the IV form starts from $956.10 and can be as much as $4,780.54.
Sarclisa is a type of targeted immunotherapy that binds to myeloma cells, exposing them to an immune system attack. It competes with Johnson & Johnson's Darzalex.
The FDA's approval was based on a late-stage trial that showed Sarclisa delivered through the device worked as well as the IV version.
The drug brought in €588 million ($671.67 million) in sales in 2025 and analysts expect €710 million this year.
