Sanofi has received China’s National Medical Products Administration (NMPA) approval for the use of Sarclisa (isatuximab), combined with a standard-of-care regimen to treat adults with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant (ASCT).
The approval is based on the positive outcomes of the IMROZ Phase III trial, which showed that the therapy, when used with bortezomib, lenalidomide and dexamethasone (VRd), improved progression-free survival compared to VRd alone.
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Sanofi Oncology global head Olivier Nataf stated: “This approval, occurring just weeks after Sarclisa’s first in the country, represents tremendous progress towards advancing this mission. Now patients with multiple myeloma and their providers have access to two new Sarclisa-based regimens that have the potential to improve outcomes across lines of therapy.”
The recent approval comes shortly after the NMPA’s December 2024 decision to approve Sarclisa plus pomalidomide and dexamethasone (Pd) for adults with relapsed or refractory MM who have undergone a minimum of one previous therapy, including lenalidomide and a proteasome inhibitor.
Sarclisa is a cluster of differentiation 38 (CD38) monoclonal antibody.
In the Asia-Pacific region, Japan is currently reviewing a regulatory submission for the antibody in NDMM subjects who are not eligible for haematopoietic stem cell transplantation.
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By GlobalDataSarclisa has received approval in more than 50 regions and countries including the European Union, Japan, China and the US, for multiple indications.
Sanofi is dedicated to the patient-centric clinical development of the antibody, with several Phase II and Phase III studies underway across the MM treatment spectrum, covering six potential indications.
The company is also exploring a subcutaneous administration method for the antibody in trials.
Sarclisa’s non-proprietary name in the US is isatuximab-irfc, following US Food and Drug Administration guidance for the industry on the naming of biological products.
In December 2024, Sanofi and SK bioscience broadened their partnership to jointly develop pneumococcal conjugate vaccines (PCVs) for paediatric and adult populations.
