The U.S. Food and Drug Administration has approved a wearable injector formulation of Sanofi’s blood cancer drug Sarclisa, offering patients with multiple myeloma a less burdensome alternative to traditional intravenous infusions. The new version, known as Sarclisa Escena, is delivered subcutaneously via an on‑body injector attached to the skin and is the first cancer medicine cleared by the FDA to be administered through such a device.
The wearable Sarclisa is approved for patients with multiple myeloma, a rare and aggressive blood cancer that begins in the bone marrow when plasma cells become malignant and multiply uncontrollably. By allowing dosing under the skin, the injector is expected to significantly cut the time patients spend in infusion centres for repeated treatment courses, while helping ease pressure on oncology clinics and nursing staff.
Sanofi has said that conventional Sarclisa infusions can take up to three hours, whereas the median injection time using the wearable device is around 13 minutes. An intravenous form of Sarclisa was first approved in the United States in 2020 for certain patients with relapsed multiple myeloma, and the latest decision extends coverage to all existing U.S. indications via the new delivery route.
The FDA’s approval is based on a late‑stage clinical trial showing that Sarclisa administered through the on‑body injector performed as well as the IV formulation in terms of efficacy. In pricing terms, Sanofi said the U.S. list price for the drug with the wearable injector is $8,796 per vial, compared with a single‑dose vial of the IV form starting at $956.10 and rising to as much as $4,780.54, underscoring the premium attached to the convenience and reduced treatment burden.
