On 20 September 2024, Sanofi announced that the US FDA has approved Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone as a first line treatment option for adult patients with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT). This approval is the third indication for Sarclisa® in the US and the first indication in newly diagnosed patients.
Sarclisa® has previously been approved in over 50 countries (in combination with pomalidomide and dexamethasone) for treatment of relapsed refractory MM (RRMM) who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor and who progressed on last therapy. Sarclisa® has also been approved (in combination with carfilzomib and dexamethasone), including in the US for the treatment of patients with RRMM who have received 1–3 prior lines of therapy and in the EU for patients with MM who have received at least one prior therapy.