Sarclisa Secures 1st Approval in China for Relapsed/Refractory Multiple Myeloma
The National Medical Products Administration (NMPA) of China has granted approval for Sarclisa (isatuximab), an anti-CD38 monoclonal antibody, in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma (MM). This approval applies to patients who have undergone at least one prior line of therapy, which includes lenalidomide and a proteasome inhibitor. The approval is based on the promising results of the pivotal ICARIA-MM phase 3 clinical trial, as well as the IsaFiRsT real-world study, which served as bridging data to support the application.
The ICARIA-MM study, conducted globally, demonstrated that Sarclisa in combination with Pd significantly reduced the risk of disease progression or death by 40%, with a hazard ratio (HR) of 0.596 (95% confidence interval [CI]: 0.44-0.81, p=0.001). This impressive result shows that Sarclisa, when used in combination with pomalidomide and dexamethasone, was associated with a clinically meaningful improvement in overall survival (OS), with a 6.9-month extension compared to the Pd regimen alone (HR=0.78; log-rank 1-sided P=0.0319).
Further strengthening the clinical evidence for Sarclisa’s effectiveness in treating relapsed or refractory multiple myeloma (R/R MM), the IsaFiRsT study, which was the first real-world study in China evaluating an anti-CD38 therapy in combination with pomalidomide and dexamethasone, reported an overall response rate (ORR) of 82.6%. This impressive outcome reinforces the role of Sarclisa as a vital treatment option for adult patients with R/R MM in China.
Olivier Nataf, Global Head of Oncology at Sanofi, expressed his enthusiasm regarding this approval, emphasizing its significance as a key milestone for the company in China. Nataf noted that the combination of the ICARIA-MM study results and the IsaFiRsT real-world study highlights the substantial benefit Sarclisa brings to patients living with multiple myeloma. He also highlighted the importance of innovative regulatory pathways, such as the use of real-world evidence (RWE), to facilitate quicker access to life-saving treatments. Sanofi remains committed to fostering strong partnerships with the medical community, local companies, and Chinese authorities to expand access to innovative therapies and improve patient outcomes.
The approval of Sarclisa by the NMPA also marks an important step in the increasing use of real-world evidence in the regulatory decision-making process in China. Over recent years, the NMPA has progressively incorporated real-world data into its review processes to expedite the approval of innovative therapies and medical devices. Sarclisa was among the first three treatments authorized for real-world studies as part of China’s Lecheng Pilot for real-world data application, becoming the first blood cancer treatment to be approved based on a combination of clinical trial data and real-world evidence. This development underscores China’s evolving approach to improving the availability of cutting-edge medical treatments.
In addition to the approval of Sarclisa-Pd for relapsed or refractory multiple myeloma, Sarclisa has also been included in the Chinese Society of Clinical Oncology (CSCO) and Chinese Anti-Cancer Association (CACA) treatment guidelines as a “Category I Recommendation” and the “Preferred Option” for patients experiencing their first relapse of multiple myeloma. These guidelines represent a critical endorsement of Sarclisa’s clinical utility in China and reflect the growing acceptance of innovative treatment options by the country’s leading oncology professionals.
Furthermore, a regulatory submission is currently under review for Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed multiple myeloma (NDMM) in adult patients who are not eligible for autologous stem cell transplantation. This combination regimen has demonstrated strong potential in earlier-stage multiple myeloma patients and, should it be approved, would further expand Sarclisa’s role in treating various stages of multiple myeloma in China. A final decision on this submission is expected within the coming months.
Sanofi’s presence in China dates back to 1982, making it one of the first multinational pharmaceutical companies to establish a foothold in the country. Over the years, Sanofi has remained committed to advancing the introduction of innovative medicines and vaccines to meet the diverse medical needs of the Chinese population. The company’s dedication to improving healthcare outcomes aligns with China’s broader goals of expanding access to cutting-edge therapies and ensuring that patients can benefit from the latest advancements in medical science.
The approval of Sarclisa in combination with pomalidomide and dexamethasone for relapsed or refractory multiple myeloma is a testament to the growing collaboration between global pharmaceutical companies like Sanofi and Chinese regulators. It also reflects the importance of innovative clinical trials and real-world data in the approval process, ultimately benefiting patients who need access to new treatment options. As the landscape of multiple myeloma therapy continues to evolve, Sanofi remains committed to advancing the science of oncology and improving the lives of patients around the world.
By integrating real-world evidence with traditional clinical trial data, the approval of Sarclisa in China serves as a landmark moment in the development and approval of cancer therapies in the region. It also sets a precedent for future treatments that may rely on similar data-driven approaches to expedite regulatory approvals. As the Chinese healthcare system continues to evolve, the use of real-world evidence will likely play a more prominent role in ensuring that patients have timely access to the most effective therapies available.
The success of Sarclisa in multiple myeloma treatment in China represents a step forward in the global fight against this complex and challenging disease. With promising clinical data, an encouraging real-world response rate, and strong regulatory support, Sarclisa is poised to become a key player in the treatment landscape for multiple myeloma, offering hope for many patients who previously had limited options for their treatment. As Sanofi continues to build its presence in China, the company remains focused on delivering innovative therapies that meet the needs of patients and healthcare providers in the country.
In conclusion, the NMPA’s approval of Sarclisa in combination with pomalidomide and dexamethasone marks an important milestone for both Sanofi and patients in China living with relapsed or refractory multiple myeloma. With this approval, Sarclisa is now positioned to provide significant benefits to patients who have not responded adequately to previous therapies, offering them a new hope in their fight against this challenging disease. The ongoing efforts to expand Sarclisa’s indications, including for newly diagnosed patients, highlight Sanofi’s continued commitment to advancing the treatment of multiple myeloma and improving patient outcomes worldwide.
