by the European Medicines Agency's Committee for Medicinal Products for Human Use on June 19, 2025, the European Commission has approved Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant..

2025年6月19日，欧洲药品管理局人用药品委员会批准后，欧盟委员会已批准Sarclisa联合硼替佐米、来那度胺和地塞米松（VRd）用于适合自体干细胞移植的新诊断多发性骨髓瘤（NDMM）成年患者的诱导治疗。

“We have been on a mission to accelerate Sarclisa’s clinical development program with the hope to bring this important medicine to as many people as possible living with multiple myeloma,” said

“我们一直在努力加速 Sarclisa 的临床开发计划，希望能够将这种重要的药物带给尽可能多的多发性骨髓瘤患者，”

Olivier Nataf

奥利维尔·纳塔夫

, Global Head of Oncology at Sanofi. “Today’s decision represents a prime example of those efforts, and most importantly, paves the way for Sarclisa to potentially become accessible to even more patients in the EU, regardless of transplant eligibility or line of therapy.”

赛诺菲全球肿瘤学主管。“今天的决定代表了这些努力的一个典型例子，最重要的是，为 Sarclisa 有可能在欧盟变得更可及铺平了道路，无论患者的移植资格或治疗阶段如何。”

The approval is based on results from

批准是基于以下结果

part one

第一部分

of the two-part, double-randomized, German-speaking Myeloma Multicenter Group (GMMG)-HD7 phase 3 study (clinical study identifier:

两部分、双随机化、德语的骨髓瘤多中心小组（GMMG）-HD7第三阶段研究（临床研究标识符：

NCT03617731

NCT03617731

), which was designed to independently assess the effects of Sarclisa during the induction and maintenance phases. Sarclisa-VRd demonstrated a deep and rapid response in transplant-eligible (TE) NDMM patients compared to VRd alone, reflected by a statistically significant minimal residual disease (MRD) negativity benefit at the end of the 18-week induction period, which was the primary endpoint of part one..

），该研究旨在独立评估Sarclisa在诱导和维持阶段的效果。与单独使用VRd相比，Sarclisa-VRd在适合移植（TE）的新诊断多发性骨髓瘤（NDMM）患者中显示出深度且快速的反应，这体现在18周诱导期结束时达到统计学显著意义的微小残留病（MRD）阴性率优势，这是第一部分的主要终点。

These MRD results were supported by the

这些MRD结果得到了支持

final progression-free survival (PFS) analysis of part one

第一部分的最终无进展生存期（PFS）分析

(induction and transplant), which demonstrated a statistically significant and clinically meaningful improvement in PFS in patients treated with Sarclisa-VRd during induction, regardless of the maintenance therapy received. Additionally, the majority (53.1%) of patients receiving Sarclisa-VRd experienced continued MRD negativity (compared to 38% in the control arm), defined as MRD negativity persisting from post-induction to post-transplant, which was consistent with the prolonged PFS benefit..

（诱导和移植），这表明在诱导期间接受 Sarclisa-VRd 治疗的患者中，无论接受何种维持治疗，其无进展生存期 (PFS) 均取得了具有统计学意义且临床显著的改善。此外，大多数 (53.1%) 接受 Sarclisa-VRd 的患者持续保持微小残留病 (MRD) 阴性（对照组为 38%），定义为从诱导后到移植后 MRD 阴性持续存在，这与延长的 PFS 获益一致。

The results are part of the growing body of clinical evidence supporting the use of Sarclisa in the front-line setting and reinforce the potential of Sarclisa-VRd when used prior to transplant. Data from part two, the maintenance portion of the study, are forthcoming.

这些结果是支持在一线环境中使用 Sarclisa 的越来越多的临床证据的一部分，并且加强了在移植前使用 Sarclisa-VRd 的潜力。第二部分的数据，即研究的维持阶段数据，即将发布。

With four approved indications globally, including two in the front-line setting, the approval further affirms Sarclisa as an established MM treatment option, reflecting Sanofi’s ambition to address critical unmet needs in MM care and make a meaningful difference in treatment outcomes at every stage of the disease..

随着全球范围内四项适应症的获批，其中包括两项在前线治疗中的应用，此次批准进一步确认了Sarclisa作为已确立的多发性骨髓瘤（MM）治疗选择的地位，体现了赛诺菲致力于满足MM治疗中关键的未满足需求，并在疾病各个阶段对治疗结果产生有意义的影响。

About the GMMG-HD7 study

关于GMMG-HD7研究

GMMG-HD7 is a pivotal, randomized, open-label, multicenter, two-part phase 3 study evaluating Sarclisa in combination with VRd, also referred to as RVd (lenalidomide, bortezomib, and dexamethasone), versus VRd induction followed by post-transplant re-randomization to Sarclisa plus lenalidomide versus lenalidomide maintenance alone in TE NDMM patients.

GMMG-HD7 是一项关键的、随机的、开放标签的、多中心的两部分三期研究，评估了 Sarclisa 联合 VRd（也称为 RVd，即来那度胺、硼替佐米和地塞米松）与 VRd 诱导治疗后进行移植后的再随机分配至 Sarclisa 加来那度胺对比单独使用来那度胺维持治疗在 TE NDMM 患者中的效果。

The GMMG-initiated study is being conducted in close collaboration with Sanofi based on jointly defined research. Sanofi provided financial support to GMMG for this study. In December 2021, Sanofi and GMMG shared results from part one, which met the primary endpoint of MRD negativity after induction therapy and before transplant in NDMM patients..

GMMG发起的这项研究是在与赛诺菲紧密合作的基础上进行的，基于共同定义的研究。赛诺菲为GMMG的这项研究提供了资金支持。2021年12月，赛诺菲和GMMG分享了第一部分的结果，该结果达到了在新诊断多发性骨髓瘤（NDMM）患者中诱导治疗后和移植前微小残留病（MRD）阴性的主要终点。

The study enrolled 662 patients with TE NDMM across 67 sites in Germany. In the first part of the study, all participants were equally randomized to receive three 42-day induction cycles of VRd in both arms of the study, while Sarclisa was added to only one study arm. After induction treatment, all patients received intensification therapy with autologous stem cell transplant.

该研究在德国67个研究中心招募了662名TE NDMM患者。在研究的第一部分，所有参与者被随机平均分配接受三个42天的VRd诱导治疗周期，而在其中一个研究组中还加入了Sarclisa。诱导治疗后，所有患者均接受了自体干细胞移植强化治疗。

In the second part of the study, patients were re-randomized post-transplant to receive Sarclisa plus lenalidomide or lenalidomide alone as maintenance therapy. During part one of the study, Sarclisa was administered through an intravenous infusion at a dose of 10 mg/kg once weekly for the first four weeks of cycle one, then every other week for the rest of the induction period..

在研究的第二部分中，患者在移植后被重新随机分配接受 Sarclisa 加来那度胺或单用来那度胺作为维持治疗。在研究的第一部分期间，Sarclisa 通过静脉输注给药，剂量为 10 mg/kg，第一周期的前四周每周一次，然后在其余诱导期内每隔一周给药。

The GMMG-HD7 protocol defined two primary endpoints: MRD negativity following induction therapy in the first part of the study, and PFS after the second randomization post-transplant in the second part, where Sarclisa was added to lenalidomide maintenance. The latter endpoint is expected to be available in due course.

GMMG-HD7协议定义了两个主要终点：研究第一部分中诱导治疗后的MRD阴性，以及第二部分中移植后第二次随机化后的PFS，其中Sarclisa被加入到来那度胺维持治疗中。后一终点预计将在适当时候公布。

The key secondary endpoint for the first part of the study was PFS from first randomization. Additional secondary endpoints included rates of complete response after induction, and intensification, overall survival, and safety..

研究第一部分的关键次要终点是从第一次随机分组开始的无进展生存期（PFS）。其他次要终点包括诱导和强化后的完全缓解率、总生存期和安全性。

MRD negativity was assessed by next-generation flow cytometry (sensitivity of 1x10

MRD阴性通过下一代流式细胞术评估（敏感性为1x10）

) after induction. In the latest results, PFS for both arms, regardless of maintenance therapy, were measured from the first randomization.

）诱导治疗后。在最新的结果中，无论是否进行维持治疗，两组的PFS均从第一次随机分组开始测量。

About Sarclisa

关于Sarclisa

Sarclisa (isatuximab) is approved in more than 50 countries, including in the US, EU, Japan, and China, across multiple lines of treatment for MM. Based on the ICARIA-MM phase 3 study, Sarclisa is approved in the US and Japan in combination with pomalidomide and dexamethasone (Pd) for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM) who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor.

Sarclisa（isatuximab）已在包括美国、欧盟、日本和中国在内的50多个国家获得批准，用于多发性骨髓瘤（MM）的多线治疗。基于ICARIA-MM三期研究，Sarclisa在美国和日本被批准与泊马度胺和地塞米松（Pd）联合使用，用于治疗接受过至少两种前期疗法（包括来那度胺和蛋白酶体抑制剂）的复发或难治性多发性骨髓瘤（R/R MM）患者。

Additionally, Sarclisa is approved in the EU in combination with Pd for the treatment of patients with R/R MM who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy, and in China for patients who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.

此外，Sarclisa在欧盟被批准与Pd联合使用，用于治疗接受过≥2种既往疗法（包括来那度胺和蛋白酶体抑制剂）且在最后一次治疗中复发的R/R MM患者；在中国，该药物被批准用于接受过至少一线既往治疗（包括来那度胺和蛋白酶体抑制剂）的患者。

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

基于IKEMA第三阶段研究，Sarclisa已在全球50多个国家获得批准，与卡非佐米和地塞米松联合使用，包括在美国用于治疗接受过一到三种前期治疗的复发/难治性多发性骨髓瘤（R/R MM）患者，以及在欧盟用于至少接受过一种前期治疗的多发性骨髓瘤（MM）患者。

In the US, EU, and China, Sarclisa is approved in combination with VRd as a front-line treatment option in transplant-ineligible NDMM patients, based on the IMROZ phase 3 study. Sarclisa is also approved in the EU in combination with VRd as an induction treatment for transplant-eligible NDMM patients, based on the GMMG-HD7 phase 3 study.

在美国、欧盟和中国，基于IMROZ三期研究，Sarclisa联合VRd被批准作为不适合移植的新诊断多发性骨髓瘤（NDMM）患者的一线治疗选择。此外，基于GMMG-HD7三期研究，Sarclisa联合VRd在欧盟也被批准用于适合移植的NDMM患者的诱导治疗。

In Japan, Sarclisa is approved in combination with VRd as a front-line treatment option regardless of transplant eligibility..

在日本，Sarclisa联合VRd获批作为前线治疗方案，无论患者是否符合移植条件。

At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need..

在赛诺菲，我们始终致力于肿瘤学领域，不断追求科学奇迹，以改善癌症患者的生活。我们致力于通过开发创新的、同类第一和最佳的免疫疗法及靶向治疗，来转变癌症护理，特别是针对那些需求未被满足的罕见且难治的癌症。

About the German-speaking Myeloma Multicenter Group

关于德语多发性骨髓瘤多中心小组

GMMG is the largest study group focusing on MM in Germany, with headquarters based in Heidelberg. Within the last 20+ years, the GMMG study group has performed numerous studies including five randomized, multicenter phase 3 studies with 4,000 patients enrolled from about 90 participating and cotreating centers throughout Germany.

GMMG是德国最大的专注于骨髓瘤（MM）的研究小组，总部位于海德堡。在过去的20多年里，GMMG研究小组开展了众多研究，其中包括五项随机、多中心的三期临床研究，共有4000名患者参与，这些患者来自德国约90个参与及共同治疗的中心。

The overall goal of GMMG is to generate improved therapies for myeloma patients through the development and testing of novel and personalized, genome- and signaling driven treatment strategies. The GMMG has set itself the goal of achieving further approvals for effective antibody-based drug combinations for the first-line treatment of myeloma patients, in which antibody-based treatment regimens have been integrated into seven GMMG study concepts (CONCEPT, DANTE, DADA, HD6, HD7, HD8, HD9 and HD10)..

GMMG 的总体目标是通过开发和测试新颖且个性化的、基于基因组和信号传导的治疗策略，为骨髓瘤患者提供更有效的治疗方法。GMMG 已将自身目标设定为在抗体药物联合疗法的一线治疗中取得更多批准，其中抗体治疗方案已被整合到七个 GMMG 研究概念中（CONCEPT、DANTE、DADA、HD6、HD7、HD8、HD9 和 HD10）。

About Sanofi

关于赛诺菲

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.

赛诺菲是一家以研发为驱动、以人工智能为助力的生物制药公司，致力于改善人们的生活并实现引人注目的增长。我们凭借对免疫系统的深刻理解，开发出能够治疗和保护全球数百万人的药物和疫苗，并通过创新的研发管线惠及更多人群。我们的团队秉承一个使命：追逐科学奇迹以改善人们的生活；这激励我们推动进步，为员工及所服务的社区带来积极影响，解决当今最紧迫的医疗、环境和社会挑战。