Sarclisa: A New Hope for Multiple Myeloma Patients in China

The pharmaceutical industry has witnessed a significant shift in recent years, with a growing emphasis on innovative treatments for life-threatening diseases. One such innovation is Sarclisa, an anti-CD38 medicine developed by Sanofi, which has recently obtained its first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma (MM). This approval marks a significant milestone for Sanofi in China and highlights the importance of innovative regulatory pathways for timely access to different treatments.

Multiple myeloma is a type of blood cancer that affects plasma cells, a type of white blood cell responsible for producing antibodies. The disease is characterized by the accumulation of abnormal plasma cells in the bone marrow, leading to bone damage, anemia, and kidney problems. Despite advancements in treatment options, multiple myeloma remains a challenging disease to manage, with a significant impact on patient quality of life and survival.

Sarclisa, in combination with pomalidomide and dexamethasone (Pd), has demonstrated promising results in clinical trials and real-world studies. The pivotal ICARIA-MM phase 3 study showed that Sarclisa in combination with Pd significantly reduced the risk of disease progression or death by 40% compared to Pd alone. Additionally, the study demonstrated a clinically meaningful, 6.9-month improvement in overall survival (OS) for patients treated with Sarclisa-Pd. Furthermore, the China-based IsaFiRsT real-world study showed an overall response rate (ORR) of 82.6% among relapsed or refractory multiple myeloma (R/R MM) adult patients treated with Sarclisa in combination with Pd.

The approval of Sarclisa in China is a testament to the growing importance of real-world evidence (RWE) in the drug approval process. The Lecheng Pilot for real-world data application has enabled the National Medical Products Administration (NMPA) to increasingly use RWE to accelerate the review and approval of innovative therapies and medical devices. Sarclisa was one of the first three treatments authorized for real-world studies as part of the pilot program and is the first blood cancer treatment approved based on RWE, in addition to clinical data.

The Chinese Society of Clinical Oncology (CSCO) and Chinese Anti-Cancer Association (CACA) have recommended Sarclisa-Pd as a "Category I Recommendation" and the "Preferred Option" for the treatment of patients with first-relapsed MM. This recommendation further solidifies Sarclisa's position in the market and increases the likelihood of prescription and reimbursement for patients in China.

Beyond R/R MM, Sanofi has submitted a regulatory submission for Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma (NDMM) in adult patients not eligible for autologous stem cell transplant. The final decision on this submission is expected in the coming months, which could further expand Sarclisa's market share in the multiple myeloma treatment landscape.

In conclusion, the approval of Sarclisa in China represents a significant milestone for Sanofi and a promising new treatment option for patients with multiple myeloma. The use of real-world evidence in the drug approval process has accelerated access to innovative therapies, leading to improved patient outcomes and increased market access for pharmaceutical companies. As Sanofi continues to build strong partnerships with the medical community, local companies, and authorities in China, the company is well-positioned to bring more innovative treatments to patients in the region.