French pharmaceutical giant Sanofi has announced the approval of its drug Sarclisa in China for adults with relapsed or refractory multiple myeloma (R/R MM). The Chinese National Medical Products Administration (NMPA) granted this first approval for Sarclisa, an anti-CD38 medication, to be used in combination with pomalidomide and dexamethasone (Pd). This treatment is designated for those who have previously undergone at least one line of therapy including lenalidomide and a proteasome inhibitor.
Sarclisa, formally known as isatuximab, works as a CD38 monoclonal antibody targeting a specific epitope on CD38 receptors found on multiple myeloma cells, thereby triggering significant antitumor effects.
The NMPA's decision was supported by findings from the pivotal ICARIA-MM Phase 3 trial, supplemented by data from the IsaFiRsT real-world study conducted in China. The ICARIA-MM trial showed that combining Sarclisa with Pd led to a 40% reduction in the risk of disease progression or death, and resulted in an improvement of 6.9 months in overall survival, in contrast to Pd alone. Additionally, the IsaFiRsT study—China’s first real-world trial for registering an anti-CD38 therapy with Pd—reported an overall response rate (ORR) of 82.6% among adults with R/R MM.
Olivier Nataf, Global Head of Oncology at Sanofi, commented, "This approval is a significant milestone for Sanofi in China. The results from both the ICARIA-MM Phase 3 and the IsaFiRsT studies underscore the benefits of Sarclisa for multiple myeloma patients and highlight the importance of innovative regulatory pathways for timely access to various treatments."
Furthermore, the Chinese Society of Clinical Oncology (CSCO) and the Chinese Anti-Cancer Association (CACA) have endorsed Sarclisa-Pd, listing it as a "Category I Recommendation" and the "Preferred Option" for treating first-relapsed multiple myeloma.
Sanofi also disclosed that a regulatory submission is under review in China for Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma in adults not eligible for autologous stem cell transplants, with a decision expected soon.
In the United States, Sarclisa is known as isatuximab-irfc, with the suffix 'irfc' aligning with the FDA's naming guidelines for biological products. Sarclisa is currently approved in over 50 countries, including the US and EU, for two indications, with an additional approval in the US for a further indication.
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