On 8 June 2026, the European Commission approved the subcutaneous (under the skin) formulation of isatuximab (Sarclisa®) for use in all myeloma indications currently approved for the intravenous (IV) formulation of isatuximab.

The newly approved subcutaneous formulation can be administered as a subcutaneous injection or using the CirCLIQ® on-body injector. This makes it the first anticancer treatment approved in the European Union to be delivered via an on-body injector.

The CirCLIQ® on-body injector is a small, single use wearable device that automatically delivers isatuximab under the skin over a short period of time. The device is designed to allow treatment administration in outpatient settings and, where permitted, at home, potentially reducing the amount of time patients spend in hospital receiving treatment.

This approval follows the favourable recommendation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March 2026, following the positive results of the IRAKLIA phase 3 study and additional supporting studies. The CHMP is the EMA committee responsible for assessing medicines and making recommendations about whether they should be approved for use.

Isatuximab is a type of targeted cancer treatment called a monoclonal antibody. It works by attaching to the CD38 protein found on the surface of myeloma cells, helping the immune system to identify and destroy these cancer cells.

Isatuximab is currently approved in the European Union in combination with:

• bortezomib, lenalidomide and dexamethasone (referred to as Isa-VRd) for transplant-eligible and transplant-ineligible newly diagnosed myeloma patients
• pomalidomide and dexamethasone (referred to as Isa-Pd) for myeloma patients who have received at least two prior therapies, including treatment with lenalidomide and a proteasome inhibitor (such as bortezomib)
• carfilzomib and dexamethasone (referred to as Isa-Kd) for myeloma patients who have received at least one prior therapy.

Availability of the subcutaneous formulation will depend on the company’s marketing plans and, in some countries, further national assessments, pricing and reimbursement decisions.