Sarclisa gains first approval in China for treating adult relapsed/refractory multiple myeloma

Sarclisa, an anti-CD38 medication developed by Sanofi, has received its first approval in China for the treatment of adults suffering from relapsed or refractory multiple myeloma (R/R MM). This significant development was announced on January 13, 2025, following the endorsement by China's National Medical Products Administration (NMPA). The approval involves Sarclisa used in combination with pomalidomide and dexamethasone (Pd), intended for patients who have undergone at least one prior treatment line involving lenalidomide and a proteasome inhibitor.

The decision to approve Sarclisa is grounded in the results of the pivotal ICARIA-MM phase 3 study, complemented by the IsaFiRsT real-world study conducted in China. The ICARIA-MM study revealed that the combination of Sarclisa and Pd reduced the risk of disease progression or death by 40%, offering a 6.9-month improvement in overall survival compared to Pd alone. Further supporting this approval, the IsaFiRsT study, the first real-world study conducted in China for an anti-CD38 therapy in this combination, showed an overall response rate of 82.6% among R/R MM patients.

This approval is seen as a milestone for Sanofi in China, emphasizing the potential benefits of Sarclisa for multiple myeloma patients. Olivier Nataf, Sanofi’s Global Head of Oncology, noted the importance of innovative regulatory pathways that enable timely access to effective treatments. Sanofi aims to continue collaborating with the medical community and local authorities in China to introduce more advanced therapies for patients.

The NMPA’s approval process leveraged real-world evidence (RWE) through the Lecheng Pilot project, which aims to expedite the approval of innovative medical treatments and devices. Sarclisa is one of the pioneering treatments approved based on RWE in conjunction with clinical data, marking a progressive step in the regulatory landscape.

Beyond R/R MM, Sarclisa-Pd is recommended as the "Category I Recommendation" and the "Preferred Option" for treating first-relapsed MM patients by the Chinese Society of Clinical Oncology (CSCO) and the Chinese Anti-Cancer Association (CACA). Additionally, a regulatory submission is underway for using Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for patients with newly diagnosed multiple myeloma (NDMM) who are not candidates for autologous stem cell transplant. A decision on this submission is expected shortly.

Sanofi, which first entered the Chinese market in 1982, is dedicated to fast-tracking the introduction of innovative medications and vaccines to transform medical practices for the benefit of the Chinese population. The company is committed to advancing Sarclisa through a patient-centric clinical development program, exploring multiple indications in phase 2 and 3 studies across the multiple myeloma treatment continuum.

Sarclisa's mechanism involves binding to the CD38 receptor on multiple myeloma cells, promoting antitumor activity. Already approved in more than 50 countries, Sarclisa is used in combination therapies for patients with relapsed or refractory multiple myeloma, with further evaluations underway for its administration and effectiveness in various treatment regimens. Sanofi continues to focus on oncology innovation, targeting difficult-to-treat cancers with significant unmet needs, striving to lead in immunoscience globally.