Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. A final decision is expected in the coming months.

• Recommendation based on GMMG-HD7 phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD negativity benefit and prolonged PFS compared to VRd alone (double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7 study - clinical study identifier: NCT03617731), presented at the 2024 American Society of Hematology Annual Meeting & Exposition and published in the Journal of Clinical Oncology).

Sarclisa is currently approved in three indications in the EU, across different lines of therapy in adult patients with relapsed and/or refractory (R/R) MM and with NDMM who are not eligible for transplant. If approved, it would represent the fourth indication in the EU and second in the front-line setting globally.

Press Release