July 22, 2026
The combination of medicine+medical device is approved by the FDA for the treatment of myeloma
Sanofi Pharmaceutical Company has received approval for the drug Sarclisa Escena (izatuximab) for the treatment of multiple myeloma. The drug can be administered automatically using a wearable device attached to the skin.
Multiple myeloma is a malignant disease of the bone marrow in which plasma cells mutate, begin to multiply uncontrollably and displace healthy hematopoiesis.
The active ingredient of the registered drug, izatuximab, is a monoclonal antibody. It blocks the CD38 protein on the surface of tumors, helping the immune system recognize and destroy them.
The efficacy and safety of the drug was proven in phase III clinical trials of IRAKLIA, where 531 participants with recurrent or refractory multiple myeloma were given the drug subcutaneously (through a body-mounted device) or intravenously. All additionally received pomalidomide and dexamethasone. Pomalidomide is an immunomodulatory drug that enhances the effect of izatuximab. Dexamethasone also enhances the overall antitumor response by inducing tumor cell death.
The effectiveness indicators practically coincided within the study: an objective response (a decrease in the level of tumor markers by half or more) was noted in 71.1 and 70.5% of volunteers in the two groups, respectively.
Izatuximab has been on the American market since 2020, but it is available in an intravenous form. The subcutaneous route of administration has several advantages: the drug is administered much faster (in 13 minutes instead of 3 hours of intravenous infusion); systemic reactions associated with the administration of the drug occur in only 1.5% of subjects (with intravenous administration – in one in four).
The device that provides the injection of the drug into the human body is a portable CirCLIQ injector from the American company Enable Injections. Its 30G diameter needle is thinner and shorter than the standard. He injects the drug in 13 minutes, after which he shuts down.
The drug was also registered in Europe in June 2026 and is the first development for the treatment of oncology administered through a wearable device.
