Following the adoption of a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), the EU has approved Sarclisa in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT), based on data from the IMROZ phase 3 study. With the expanded marketing authorization, Sarclisa is the first anti-CD38 therapy in combination with VRd in this patient population in the EU.

在采用正面评价根据来自的数据，欧洲药品管理局 （EMA） 人用药品委员会 （CHMP） 已批准 Sarclisa 与标准护理方案硼替佐米、来那度胺和地塞米松 （VRd） 联合用于治疗不符合自体干细胞移植 （ASCT） 条件的新诊断多发性骨髓瘤 （NDMM） 成年患者IMROZ 3 期研究.随着扩大的上市许可，Sarclisa 是欧盟该患者群体中首个与 VRd 联合的抗 CD38 疗法。

Olivier Nataf Global Head of Oncology at Sanofi “While there have been many important advancements in multiple myeloma treatment over the past decade, there remains a significant unmet need in the front-line setting, particularly for transplant-ineligible patients. With today’s decision the 27 countries in the EU will have access to a potentially transformative new combination regimen, marking a significant step forward in our mission to make a meaningful difference in multiple myeloma treatment.”

赛诺菲全球肿瘤学负责人 Olivier Nataf“虽然过去十年中多发性骨髓瘤治疗取得了许多重要进展，但一线医疗领域仍然存在大量未满足的需求，特别是对于不适合移植的患者。根据今天的决定，欧盟 27 个国家将获得可能具有变革性的新联合方案，这标志着我们在多发性骨髓瘤治疗方面做出有意义改变的使命向前迈出了重要一步。

In September 2024, the US Food and Drug Administration (FDA) approved Sarclisa in combination with VRd for the treatment of adult patients with NDMM who are not eligible for ASCT, representing the first global approval for Sarclisa in the front-line setting. In addition, the FDA granted orphan drug exclusivity for Sarclisa in the approved indication. Beyond the US and the EU, regulatory submissions for Sarclisa in NDMM not eligible for ASCT are under review in Japan and in China.

2024 年 9 月，美国食品药品监督管理局 （FDA）批准Sarclisa 与 VRd 联合用于治疗不符合 ASCT 条件的成年 NDMM 患者，这是 Sarclisa 在一线环境中的首次全球批准。此外，FDA 还授予 Sarclisa 在已批准适应症中的孤儿药排他性。在美国和欧盟之外，日本和中国正在审查不符合 ASCT 条件的 Sarclisa in NDMM 的监管申请。

About Sarclisa

关于Sarclisa

Sarclisa (isatuximab) is a CD38 monoclonal antibody that binds to a specific epitope on the CD38 receptor on MM cells, inducing distinct antitumor activity. It is designed to work through multiple mechanisms of action including programmed tumor cell death (apoptosis) and immunomodulatory activity. CD38 is highly and uniformly expressed on the surface of MM cells, making it a target for antibody-based therapeutics such as Sarclisa.

Sarclisa（isatuximab）是一种CD38单克隆抗体，可与MM细胞CD38受体上的特定表位结合，诱导独特的抗肿瘤活性。它旨在通过多种作用机制发挥作用，包括程序性肿瘤细胞死亡（凋亡）和免疫调节活性。CD38在MM细胞表面高度均匀表达，使其成为基于抗体的治疗剂（如Sarclisa）的靶标。

In the US, the non-proprietary name for Sarclisa is isatuximab-irfc, with irfc as the suffix designated in accordance with nonproprietary naming of biological products guidance for industry issued by the US FDA..

在美国，Sarclisa的非专有名称是isatuximab irfc，irfc是根据美国FDA发布的《生物制品行业非专有命名指南》指定的后缀。。

Currently, Sarclisa is approved in more than 50 countries, including the US and in the EU, across three indications. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in combination with pomalidomide and dexamethasone (Pd) for the treatment of patients with relapsed or refractory MM (R/R MM) who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor, and who progressed on last therapy.

目前，Sarclisa已在包括美国和欧盟在内的50多个国家获得三种适应症的批准。根据ICARIA-MM 3期研究，Sarclisa被批准与pomalidomide和地塞米松（Pd）联合用于治疗复发或难治性MM（R/R MM）患者，这些患者先前接受过≥2次治疗，包括来那度胺和蛋白酶体抑制剂，并且在最后一次治疗中取得了进展。

Based on the IKEMA phase 3 study, Sarclisa is also approved in 50 countries in combination with carfilzomib and dexamethasone, including in the US for the treatment of patients with R/R MM who have received 1–3 prior lines of therapy and in the EU for patients with MM who have received at least 1 prior therapy.

根据IKEMA 3期研究，Sarclisa还被50个国家批准与卡非佐米和地塞米松联合使用，包括在美国用于治疗先前接受过1-3次治疗的R/R MM患者，在欧盟用于治疗至少接受过1次治疗的MM患者。

In the US and EU, Sarclisa is approved in combination with VRd as a front-line treatment option for adult patients with NDMM, who are not eligible for ASCT, based on the IMROZ phase 3 study..

根据IMROZ 3期研究，在美国和欧盟，Sarclisa被批准与VRd联合作为成人NDMM患者的一线治疗选择，这些患者不符合ASCT的资格。。

Sanofi continues to advance Sarclisa as part of a patient-centric clinical development program, which includes several phase 2 and phase 3 studies across the MM treatment continuum spanning six potential indications. In addition, the company is evaluating a subcutaneous administration method for Sarclisa in clinical studies.

赛诺菲继续推进Sarclisa作为以患者为中心的临床开发计划的一部分，该计划包括跨越六个潜在适应症的MM治疗连续体的几项2期和3期研究。此外，该公司正在临床研究中评估Sarclisa的皮下给药方法。

The safety and efficacy of Sarclisa has not been evaluated by any regulatory authority outside of its approved indications and methods of delivery..

除了批准的适应症和分娩方法外，任何监管机构都没有对Sarclisa的安全性和有效性进行评估。。

In striving to become the number one immunoscience company globally, Sanofi remains committed to advancing oncology innovation. Through focused strategic decisions the company has reshaped and prioritized its pipeline, leveraging its expertise in immunoscience to drive progress. Efforts are centered on difficult-to-treat often rare cancers such as select hematologic malignancies and solid tumors with critical unmet needs, including multiple myeloma, acute myeloid leukemia, certain types of lymphomas, as well as gastrointestinal and lung cancers..

在努力成为全球第一大免疫科学公司的过程中，赛诺菲仍然致力于推进肿瘤学创新。通过有针对性的战略决策，该公司重塑并优先考虑了其渠道，利用其在免疫科学方面的专业知识来推动进步。努力的重点是难以治疗的罕见癌症，如选择性血液恶性肿瘤和严重未满足需求的实体瘤，包括多发性骨髓瘤，急性髓细胞白血病，某些类型的淋巴瘤，以及胃肠道和肺癌。。

About Sanofi

关于赛诺菲

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions..

我们是一家创新的全球医疗保健公司，其宗旨是：追求科学奇迹，改善人们的生活。我们在世界各地的团队致力于通过将不可能变为可能来改变医学实践。我们为全球数百万人提供潜在的改变生命的治疗方案和挽救生命的疫苗保护，同时将可持续性和社会责任作为我们雄心壮志的核心。。