Sanofi has received the European Union (EU) approval for Sarclisa (isatuximab-irfc) in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd) to treat certain multiple myeloma patients.
Sarclisa with VRd is now approved to treat adults with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT).
The approval follows a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Sarclisa in November 2024.
Based on this expanded marketing authorisation, Sarclisa is said to be the first anti-CD38 medication in the EU to be used in conjunction with VRd for this patient population.
This is the third indication in the EU, along with two for treating adult relapsed/refractory multiple myeloma (R/R MM) patients and one for NDMM.
The first worldwide approval of Sarclisa in a front-line context occurred in September 2024 when the US Food and Drug Administration (FDA) authorised Sarclisa and VRd for patients with NDMM who are not eligible for ASCT.
Furthermore, isatuximab was given orphan medication exclusivity by the FDA in the approved indication.
In addition to the US and the EU, China and Japan are reviewing regulatory submissions for Sarclisa in NDMM that are not eligible for ASCT.
Sanofi oncology global head Olivier Nataf said: “While there have been many important advancements in multiple myeloma treatment over the past decade, there remains a significant unmet need in the front-line setting, particularly for transplant-ineligible patients.
“With today’s decision the 27 countries in the EU will have access to a potentially transformative new combination regimen, marking a significant step forward in our mission to make a meaningful difference in multiple myeloma treatment.”
The latest approval is based on positive results from the IMROZ phase 3 study.
According to the results, isatuximab in combination with standard-of-care treatment improved Progression-free survival (PFS), compared to the standard of care alone in TI NDMM.
Sarclisa is still being developed by Sanofi as part of a clinical development programme that comprises several phase 2 and phase 3 studies covering six possible indications within the MM therapy continuum.
The business is also conducting clinical trials to assess a subcutaneous delivery system for Sarclisa.
