PRINCETON N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has expanded approval of Reblozyl® (luspatercept) to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS).

普林斯顿新泽西州（商业新闻短讯）--百时美施贵宝（纽约证券交易所：BMY）今天宣布，欧盟委员会（EC）已扩大对Reblozyl®（luspatercept）的批准，以包括对因极低，低和中等风险骨髓增生异常综合征（MDS）引起的输血依赖性贫血成年患者的一线治疗。

This approval of Reblozyl covers all EU member states.

Reblozyl的批准涵盖了所有欧盟成员国。

“With this approval for Reblozyl as a first-line treatment for anemia in adults with lower-risk MDS, more patients in the EU will have the potential to become transfusion independent for longer periods of time compared to current options available,” said Monica Shaw, M.D., senior vice president and head of European Markets, Bristol Myers Squibb.

百时美施贵宝高级副总裁兼欧洲市场总监莫妮卡·肖（MonicaShaw，M.D.）说：“随着雷布唑被批准作为MDS风险较低的成年人贫血的一线治疗药物，与目前可用的选择相比，更多的欧盟患者将有可能在更长的时间内独立输血。”

“This milestone underscores our ongoing commitment to developing new options for patients with disease-related anemia.”.

“这一里程碑强调了我们正在致力于为疾病相关贫血患者开发新的选择。”

The approval is based on the pivotal Phase 3 COMMANDS study, in which Reblozyl demonstrated superior efficacy compared to epoetin alfa, an erythropoiesis stimulating agent, in the study’s primary endpoint of concurrent red blood cell transfusion independence and hemoglobin increase. Safety results were consistent with previous MDS studies and were in line with expected symptoms in this patient population.

该批准基于关键的3期COMMANDS研究，在该研究中，与促红细胞生成刺激剂epoetin alfa相比，Reblozyl在同时红细胞输血独立性和血红蛋白增加的主要终点方面表现出优越的疗效。安全性结果与之前的MDS研究一致，并且与该患者人群的预期症状一致。

Reblozyl is also approved in the United States and Japan for the first-line treatment of anemia associated with lower-risk MDS..

Reblozyl在美国和日本也被批准用于与低风险MDS相关的贫血的一线治疗。

“In the treatment of lower-risk MDS, few patients experience a lasting response to erythroid stimulating agents, leaving a critical need for more effective treatment options to address the burden of their anemia,” said Matteo Giovanni Della Porta, M.D., study investigator and head of Leukemia Unit at Humanitas Cancer Center in Milan, Italy.

“在低风险MDS的治疗中，很少有患者对红细胞刺激剂有持久的反应，因此迫切需要更有效的治疗选择来解决他们的贫血负担，”意大利米兰Humanitas癌症中心白血病科主任兼研究调查员Matteo Giovanni Della Porta医学博士说。

“Results from the COMMANDS study underscore the clinical value of Reblozyl as an initial treatment for anemia in patients with low- to intermediate-risk MDS, and this approval represents a significant milestone towards improving treatment practice and offering better outcomes for patients.”.

“COMMANDS研究的结果强调了雷布唑作为中低风险MDS患者贫血初始治疗的临床价值，这一批准代表了改善治疗实践和为患者提供更好结果的重要里程碑。”

*Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland and Wales).

*集中营销授权不包括英国（英格兰、苏格兰和威尔士）的批准。

About COMMANDS

关于命令

COMMANDS (NCT03682536) is a Phase 3, open-label, randomized study evaluating the efficacy and safety of Reblozyl versus epoetin alfa for the treatment of anemia due to very low-, low- or intermediate-risk (IPSS-R) myelodysplastic syndromes (MDS) in patients who are red blood cell (RBC) transfusion dependent and were erythropoiesis stimulating agent (ESA)-naïve..

COMMANDS（NCT03682536）是一项3期开放标签随机研究，评估雷布唑与epoetin alfa治疗极低，低或中等风险（IPSS-R）骨髓增生异常综合征（MDS）引起的贫血的疗效和安全性。红细胞（RBC）输注依赖性和红细胞生成刺激剂（ESA）天真的患者。

The primary endpoint evaluated in this study is RBC transfusion independence (RBC-TI) for 12 weeks with a mean hemoglobin (Hb) increase ≥1.5 g/dL. Key secondary endpoints include erythroid response (HI-E) of at least 8 weeks during weeks 1-24 of the study, RBC-TI ≥12 weeks and RBC-TI for 24 weeks. Eligible patients were ≥18 years old with lower-risk MDS who require transfusions.

本研究评估的主要终点是红细胞输血独立性（RBC-TI），持续12周，平均血红蛋白（Hb）增加≥1.5 g/dL。关键的次要终点包括研究第1-24周至少8周的红细胞反应（HI-E），RBC-TI≥12周和RBC-TI持续24周。符合条件的患者年龄≥18岁，需要输血的MDS风险较低。

Patients were randomized 1:1 to receive subcutaneous Reblozyl (starting dose 1.0 mg/kg, titration up to 1.75 mg/kg) once every 3 weeks or epoetin alfa (starting dose 450 IU/kg, titration up to 1050 IU/kg) weekly for ≥24 weeks..

患者以1:1的比例随机分组，每3周一次皮下注射雷布唑（起始剂量1.0 mg/kg，滴定至1.75 mg/kg），或每周服用依泊汀（起始剂量450 IU/kg，滴定至1050 IU/kg），持续≥24周。

At the time of the primary analysis (March 31, 2023), 363 patients were randomized 1:1 to Reblozyl and epoetin alfa. Results from the primary analysis of the intent to treat (ITT) population showed:

在初步分析时（2023年3月31日），363名患者以1:1的比例随机分配到雷布唑和依泊汀阿尔法。意向治疗（ITT）人群的初步分析结果显示：

60.4% (n=110) of patients receiving Reblozyl vs. 34.8% (n=63) of patients receiving epoetin alfa achieved the primary endpoint of RBC-TI of at least 12 weeks with concurrent mean Hb increase of at least 1.5 g/dL within the first 24 weeks (p