Sanofi, a leading French Healthcare group, continues to push the boundaries of medical innovation. China’s National Medical Products Administration (NMPA) recently approved Sarclisa (isatuximab) for the treatment of relapsed or refractory multiple myeloma in adults, marking a significant advancement in the fight against this complex disease.
Clinical trial results
The approval of Sarclisa is based on impressive results from two major trials:
• ICARIA-MM pivotal phase III trial: This study demonstrated that Sarclisa, in combination with pomalidomide and dexamethasone (Pd regimen), reduces the risk of disease progression or death by 40%, and improves overall survival by 6.9 months.
• Real-life IsaFiRsT trial: Conducted in China, this study confirmed the effectiveness of Sarclisa, with an overall response rate of 82.6% in patients with relapsed or refractory multiple myeloma.
Recommendations and impact
The Sarclisa-Pd association is now recommended by:
• The Chinese Society of Clinical Oncology
• The Chinese Anti-Cancer Association
This approval provides a new treatment option for Chinese patients, significantly improving their treatment prospects and quality of life.
Sanofi’s commitment to China
Sanofi is committed to fast-tracking the introduction of innovative medicinal products in China, working closely with the medical community and local authorities. This strategy helps to transform the practice of medicine and to meet the needs of patients efficiently and quickly.
Continuous innovation
Sanofi continues to evaluate Sarclisa via several phase II and III clinical trials, exploring new indications and delivery methods. This commitment to research and development highlights Sanofi’s position as a global leader in healthcare innovation.
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