On 14 November 2024, Sanofi announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT). This follows approval of Sarclisa® for multiple myeloma by the US FDA in September 2024.
On 12 November 2024, FirstWord Pharma reported that Sanofi has succeeded in an appeal in the UK against the NICE’s June 2024 Final Draft Guidance recommending against Sarclisa® as a regimen alongside pomalidomide and dexamethasone for relapsed relapsed/refractory multiple myeloma (RRMM). NICE has agreed to re-assess Sarclisa® at a third Committee Meeting.
This follows Sanofi’s announcement in September 2024 that the US FDA approved a new indication of Sarclisa® in combination with bortezomib, lenalidomide, and dexamethasone as a first line treatment option for adult patients with NDMM who are not eligible for autologous stem cell transplant. Sarclisa® has previously been approved in over 50 countries (in combination with pomalidomide and dexamethasone) for treatment of RRMM in patients who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor and who progressed on last therapy.