The European panel has expanded delivery options for multiple myeloma by approving a subcutaneous (SC) option for a key anti‑CD38 myeloma therapy.

At its March 2026 meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for a SC formulation of Sarclisa (isatuximab, Sanofi). The new formulation provides a significant alternative to the standard intravenous (IV) infusion, which often requires lengthy chair time for patients.

The recommendation adds a new route of administration, a new pharmaceutical form as a solution for injection, and a new 1400-mg strength.

If approved by the European Commission, the formulation could be given either by manual injection or via an on-body injector, offering an alternative to the standard IV infusion. The CHMP opinion applies across all existing approved indications for Sarclisa in newly diagnosed and relapsed/refractory multiple myeloma. 

Isatuximab is a monoclonal antibody that targets the CD38 protein found in high concentrations on multiple myeloma cells. By binding to CD38, the drug activates the immune system to eliminate cancer cells. 

Existing Treatment Landscape 

The therapeutic indications for Sarclisa remain unchanged by this new delivery method. It continues to be indicated in combination with:

• pomalidomide/dexamethasone: For adults with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and whose disease progressed on the last therapy
• carfilzomib/dexamethasone: For patients with multiple myeloma who have received at least one prior therapy
• bortezomib/lenalidomide/dexamethasone: For the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant
• bortezomib/lenalidomide/dexamethasone: For the induction treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant 

Efficacy and Safety Evidence 

The recommendation is primarily supported by the phase 3 IRAKLIA study, which demonstrated that the SC formulation is noninferior to IV administration.

In patients with relapsed/refractory multiple myeloma, the SC formulation achieved an objective response rate of 71.1% compared with 70.5% for the IV route. The route demonstrated good tolerability in clinical trials, with injection site reactions occurring in only 0.4% of injections, all of which were grade 1 or 2.

Notably, infusion or injection reactions fell from 25.0% with IV delivery to just 1.5% with SC delivery. 

Patient satisfaction was also higher with the SC method, with 70.0% of patients expressing satisfaction compared with 53.4% for IV treatment.

Similar results were observed in earlier phase 2 IZALCO study, which indicated comparable efficacy with IV route and higher patient satisfaction and a strong preference for SC delivery over traditional IV infusions.

Detailed guidance on the SC formulation will be provided in the updated Summary of Product Characteristics, to be published after the European Commission issues its decision on the marketing authorization change.