By Sneha S K and Bhanvi Satija
July 10 (Reuters) – 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 gives the French drugmaker a regulatory win as new CEO Belén Garijo seeks to reduce investor concerns about reliance on asthma drug Dupixent, its biggest-selling medicine. Sanofi, last month, named Paulo Fontoura as its new R&D head.
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 intravenous form.
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 in the anti-CD38 class of multiple myeloma drugs.
The FDA’s approval, which came after an extension of review by three months, was based on a late-stage trial that showed Sarclisa delivered through the device worked as well as the intravenous version.
The drug brought in €588 million ($671.67 million) in sales in 2025 and analysts expect €710 million this year.
($1 = 0.8754 euros)
(Reporting by Sneha S K in Bengaluru and Bhanvi Satija in London; Editing by Shreya Biswas and Sahal Muhammed)
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