Sanofi’s Sarclisa gains approval in China for multiple myeloma treatment

CHINA— French drugmaker Sanofi has received approval from China’s National Medical Products Administration (NMPA) for its drug Sarclisa (isatuximab).

This approval allows the drug to be used in combination with a standard treatment regimen for adults with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplants (ASCT).

This decision follows the positive results from the IMROZ Phase III clinical trial, which demonstrated that the combination of Sarclisa with bortezomib, lenalidomide, and dexamethasone (VRd) improved progression-free survival compared to the use of VRd alone.

Olivier Nataf, Global Head of Sanofi Oncology, expressed excitement over this approval, noting that it marks a significant step forward in providing new treatment options for patients with multiple myeloma.

 He emphasized that the approval, which comes shortly after Sarclisa’s initial approval in China, now offers healthcare providers and patients access to two Sarclisa-based regimens. These treatments can potentially enhance outcomes across different stages of the disease.

This approval in China follows the NMPA’s decision in December 2024 to approve Sarclisa in combination with pomalidomide and dexamethasone (Pd) for treating relapsed or refractory multiple myeloma in adults who have received at least one previous therapy, including lenalidomide and a proteasome inhibitor.

Sarclisa is a monoclonal antibody that targets the CD38 receptor, which is highly expressed on multiple myeloma cells.

By binding to this receptor, Sarclisa triggers several mechanisms to combat the disease, including promoting tumor cell death and stimulating immune system activity. This makes it a powerful treatment option for multiple myeloma patients.

In addition to its approval in China, Sarclisa is already authorized for multiple indications in over 50 regions and countries, including the European Union, Japan, and the United States.

In Japan, a regulatory review is ongoing for its use in NDMM patients who are not eligible for hematopoietic stem cell transplantation.

Sanofi is committed to advancing Sarclisa’s development through numerous ongoing Phase II and Phase III trials, aiming to expand its use across different stages of multiple myeloma.

The company is also investigating subcutaneous administration of the drug to make treatment more convenient for patients.

In December 2024, Sanofi expanded its partnership with SK Bioscience to jointly develop pneumococcal conjugate vaccines (PCVs) for both pediatric and adult populations, further strengthening their focus on advancing healthcare globally.

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