Two head-to-head phase III trials demonstrated superior efficacy, including overall survival versus a daratumumab-based triplet in DREAMM-7

两项头对头的 III 期试验显示了优越的疗效，包括在 DREAMM-7 中与基于达雷妥尤单抗的三联疗法相比的总生存期。

Blenrep

Blenrep

, a first-in-class anti-BCMA ADC, could transform treatment as early as first relapse where additional effective and accessible options are needed

，一种首创的抗BCMA ADC，可以在最早复发时改变治疗方式，在这个阶段需要更多有效且可及的治疗选择。

1,2,3

1,2,3

Sixth regulatory approval for

第六项监管批准

Blenrep

Blenrep

combinations with applications under review in all major markets

在所有主要市场中正在审查的应用组合

GSK plc (LSE/NYSE: GSK) today announced the approval of

葛兰素史克公司（LSE/NYSE：GSK）今天宣布批准了

Blenrep

Blenrep

in the European Union (EU) for the treatment of adults with relapsed or refractory multiple myeloma in combination with bortezomib plus dexamethasone (BVd) in patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) in patients who have received at least one prior therapy including lenalidomide..

在欧盟（EU），用于治疗接受过至少一种先前疗法的复发或难治性多发性骨髓瘤成人患者，与硼替佐米加地塞米松（BVd）联合使用；以及与泊马度胺加地塞米松（BPd）联合使用于接受过至少一种先前疗法（包括来那度胺）的患者。

The approval is based on superior efficacy results demonstrated by

批准基于优越的疗效结果

Blenrep

Blenrep

combinations in the pivotal DREAMM-7 and DREAMM-8 phase III trials in relapsed or refractory multiple myeloma. These include statistically significant and clinically meaningful progression-free survival (PFS) for

在关键的DREAMM-7和DREAMM-8三期临床试验中，复发或难治性多发性骨髓瘤的组合包括具有统计学显著性和临床意义的无进展生存期（PFS）。

Blenrep

Blenrep

combinations versus triplet standard of care combinations in both trials and overall survival (OS) versus a daratumumab-based triplet in DREAMM-7.

在两项试验中，组合疗法与三联标准疗法的对比，以及在DREAMM-7研究中总生存期（OS）与基于达拉图单抗的三联疗法的对比。

2,3,4

2，3，4

The safety and tolerability profiles of the

安全性和耐受性特征

Blenrep

Blenrep

combinations were broadly consistent with the known profiles of the individual agents.

组合与已知的个别药物的特性大致一致。

2,3

2,3

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, sai

葛兰素史克（GSK）全球肿瘤研发高级副总裁兼全球负责人赫沙姆·阿卜杜拉说

d: “Today’s approval of

d: “今天的批准

Blenrep

Blenrep

combinations is a redefining moment for patients with relapsed or refractory multiple myeloma in the EU.

组合疗法是欧盟复发或难治性多发性骨髓瘤患者的重新定义时刻。

Blenrep

Blenrep

has the potential to extend remission and survival, with superior efficacy versus standards of care in our DREAMM clinical trial programme and the option to administer in both academic and community-based settings.”

在我们的DREAMM临床试验项目中，有可能延长缓解期和生存期，其疗效优于现有的护理标准，并且可以在学术和社区环境中进行管理。

More than 50,000 cases of multiple myeloma are diagnosed in Europe each year, accounting for more than a quarter of global incidence.

每年在欧洲诊断出超过50,000例多发性骨髓瘤病例，占全球发病率的四分之一以上。

5

5

Blenrep

Blenrep

is the only anti-BCMA (B-cell maturation antigen) antibody-drug conjugate (ADC) approved in multiple myeloma, providing patients with a differentiated mechanism of action to potentially help slow disease progression and extend survival.

是唯一获准用于多发性骨髓瘤的抗BCMA（B细胞成熟抗原）抗体药物偶联物（ADC），为患者提供了一种独特的作用机制，可能有助于减缓疾病进展并延长生存期。

1

1

Blenrep

Blenrep

combinations can be administered to a range of patient types across oncology treatment settings, enabling broad accessibility of an anti-BCMA therapy.

这些组合可以在肿瘤治疗的不同场景中应用于各类患者，从而使抗BCMA疗法具有广泛的可及性。

María-Victoria Mateos, MD, PhD, Head of Myeloma and Clinical Trials Unit, Haematology Department and Professor of Medicine at the University of Salamanca, Spain, and DREAMM-7 principal investigator, said

西班牙萨拉曼卡大学血液科骨髓瘤和临床试验部门负责人、医学教授玛丽亚-维多利亚·马特奥斯（María-Victoria Mateos），医学博士、哲学博士，以及DREAMM-7项目的主要研究者表示：

: “With the approval of

：“经批准，

Blenrep

Blenrep

combinations in the EU, we now have additional tools in our efforts to keep patients in remission longer, maintain quality of life and extend survival. The robust efficacy supported by the DREAMM-7 and DREAMM-8 trials, together with manageable outpatient administration in academic and community settings, positions .

在欧盟的组合疗法中，我们现在有更多工具来努力让患者更长时间地保持缓解状态、维持生活质量并延长生存期。DREAMM-7 和 DREAMM-8 试验所支持的强大疗效，加上在学术和社区环境中可管理的门诊治疗，为我们提供了有力的支持。

Blenrep

Blenrep

combinations as a fundamentally differentiated treatment approach for multiple myeloma patients starting from first relapse.”

从第一次复发开始，将组合疗法作为多发性骨髓瘤患者的一种基本差异化的治疗方案。

Both DREAMM-7 and DREAMM-8 showed statistically significant and clinically meaningful PFS improvements for the

DREAMM-7 和 DREAMM-8 均显示出具有统计学意义且临床显著的 PFS 改善，对于

Blenrep

Blenrep

combinations compared to standard of care triplet combinations in the second line or later treatment of multiple myeloma.

与多发性骨髓瘤二线或后期治疗中的标准三联组合相比的组合。

2,3

2,3

In DREAMM-7, the

在DREAMM-7中，

Blenrep

Blenrep

combination (n=243) nearly tripled median PFS versus the daratumumab-based comparator (n=251) (36.6 months versus 13.4 months, respectively (hazard ratio [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53], p-value<0.00001).

组合疗法（n=243）的中位无进展生存期（PFS）几乎是基于达雷妥尤单抗的对照组（n=251）的三倍（分别为36.6个月和13.4个月，风险比[HR]：0.41 [95%置信区间（CI）：0.31-0.53]，p值<0.00001）。

2

2

DREAMM-7 also met the key secondary endpoint of OS, showing a statistically significant and clinically meaningful 42% reduction in the risk of death at a median follow-up of 39.4 months favouring the

DREAMM-7 也达到了关键的次要终点 OS，显示出在中位随访时间为 39.4 个月时，死亡风险显著降低了 42%，这一结果具有统计学意义和临床意义，支持了该方案。

Blenrep

Blenrep

combination versus the daratumumab-based comparator (HR: 0.58; 95% CI: 0.43-0.79; p=0.00023). The median OS was not reached in either arm of the study. The three-year OS rate was 74% in the

与基于达拉图单抗的对照组相比（HR：0.58；95% CI：0.43-0.79；p=0.00023）。研究的两组均未达到中位总生存期。三年总生存率为74%。

Blenrep

Blenrep

combination arm and 60% in the daratumumab combination arm.

组合臂和达拉图单抗组合臂中为60%。

4

4

In DREAMM-8, at a median follow-up of 21.8 months, the median PFS was not yet reached (95% CI: 20.6-not yet reached [NR]) with the

在 DREAMM-8 中，中位随访时间为 21.8 个月，中位 PFS 尚未达到（95% CI：20.6-尚未达到 [NR]）。

Blenrep

Blenrep

combination compared to 12.7 months in the bortezomib combination (95% CI: 9.1-18.5) at the time of primary analysis.

与硼替佐米联合治疗的12.7个月相比（95%置信区间：9.1-18.5），在初步分析时。

3

3

Blenrep

Blenrep

combinations consistently benefited a broad range of patients, including those with poor prognostic features or outcomes, such as high-risk cytogenetics or those refractory to lenalidomide. Both trials also showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses versus the respective comparators..

组合疗法持续使广泛患者获益，包括那些预后特征或结果较差的患者，例如高危细胞遗传学或对来那度胺耐药的患者。两项试验还显示，在所有其他次要疗效终点上均有临床意义上的改善，包括相较于各自对照组更深入且更持久的反应。

2,3

2,3

DREAMM-7 and DREAMM-8 showed that eye-related side effects associated with

DREAMM-7 和 DREAMM-8 显示与眼部相关的副作用

Blenrep

Blenrep

can be managed and reversed with appropriate dose modifications and follow-up. This allowed patients to maintain benefit and resulted in low rates of discontinuation due to eye-related side effects (≤9%) in both trials.

可以通过适当的剂量调整和随访来管理并逆转。这使得患者能够维持获益，并且在两项试验中，因眼部相关副作用导致的停药率较低（≤9%）。

2,3

2,3

The most commonly reported non-ocular adverse events (>30% of participants) in the

最常报告的非眼部不良事件（超过30%的参与者）包括

Blenrep

Blenrep

combination arm were thrombocytopenia (87%) and diarrhoea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%) and COVID-19 (37%) in DREAMM-8.

在DREAMM-7中，联合用药组的不良反应主要是血小板减少症（87%）和腹泻（32%），而在DREAMM-8中则是中性粒细胞减少症（63%）、血小板减少症（55%）和新冠肺炎（37%）。

2,3

2,3

Blenrep

Blenrep

combinations are also approved in relapsed or refractory multiple myeloma in the

组合也适用于复发或难治性多发性骨髓瘤患者。

UK

英国

6

6

and

和

Japan

日本

7

7

as well as other markets, including Canada and Switzerland (based on the results of DREAMM-8). Applications are currently under review in all major markets globally, including the

以及包括加拿大和瑞士在内的其他市场（基于DREAMM-8的结果）。目前，全球所有主要市场的申请正在审查中，包括

US

美国

8

8

and

和

China

中国

9

9

(based on the results of DREAMM-7, with Breakthrough Therapy Designation for the combination and priority review for the application).

（基于DREAMM-7的结果，联合疗法获得了突破性治疗指定，且申请获得了优先审查）。

About multiple myeloma

关于多发性骨髓瘤

Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable.

多发性骨髓瘤是全球第三常见的血液癌症，通常被认为可治疗但无法治愈。

10,11

10，11

There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.

全球每年约有超过180,000例新诊断的多发性骨髓瘤病例。

5

5

Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.

由于多发性骨髓瘤通常对现有治疗产生耐药性，因此需要研究新的疗法。

1

1

Many patients with multiple myeloma are treated in a community cancer setting, leaving an urgent need for new, effective therapies with manageable side effects that can be administered outside of an academic centre.

许多多发性骨髓瘤患者在社区癌症环境中接受治疗，这使得迫切需要新的、有效的、副作用可管理的疗法，这些疗法可以在学术中心之外进行施用。

12,13

12，13

About

关于

Blenrep

Blenrep

Blenrep

Blenrep

is an ADC comprising a humanised BCMA monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen Inc.; the monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa Inc., a member of the Kyowa Kirin Group..

是一种由人源化的BCMA单克隆抗体通过不可裂解的连接子与细胞毒性药物auristatin F结合而成的抗体药物偶联物（ADC）。该药物连接子技术获Seagen Inc.授权；单克隆抗体使用从属于协和麒麟集团的BioWa Inc.授权的POTELLIGENT技术生产。

Indication

指示

In the EU,

在欧盟，

Blenrep

Blenrep

is indicated in adults for the treatment of relapsed or refractory multiple myeloma:

成人用于治疗复发性或难治性多发性骨髓瘤：

in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and

与硼替佐米和地塞米松联合用于已接受至少一种先前治疗的患者；以及

in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.

与泊马度胺和地塞米松联合用于接受过至少一种先前治疗（包括来那度胺）的患者。

IMPORTANT SAFETY INFORMATION FOR

重要安全信息

BLENREP

BLENREP

Refer to the

参考以下内容，

Blenrep

Blenrep

EMA Reference Information

欧洲药品管理局参考信息

14

14

which will soon be available for a full list of adverse events and the complete important safety information in the EU.

即将提供完整的不良事件列表和欧盟地区的重要安全信息。

About DREAMM-7

关于DREAMM-7

DREAMM-7 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin combined with bortezomib plus dexamethasone (BVd) compared to daratumumab combined with bortezomib plus dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma who previously were treated with at least one prior line of multiple myeloma therapy, with documented disease progression during or after their most recent therapy.

DREAMM-7 是一项多中心、开放标签、随机 III 期临床试验，评估了贝兰他单抗马福多汀联合硼替佐米加地塞米松（BVd）与达雷妥尤单抗联合硼替佐米加地塞米松（DVd）在既往接受过至少一种多发性骨髓瘤治疗方案并在最近一次治疗期间或之后有记录疾病进展的复发性或难治性多发性骨髓瘤患者中的疗效和安全性。

The trial enrolled 494 participants who were randomised 1:1 to receive either BVd or DVd. Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously every three weeks in combination for the first eight cycles and then continued as a single agent. The primary endpoint was PFS as per an independent review committee, with secondary endpoints including OS, duration of response (DOR), and minimal residual disease (MRD) negativity rate as assessed by next-generation sequencing.

试验共纳入494名参与者，他们以1:1的比例随机分配接受BVd或DVd治疗。贝兰他单抗美多汀以2.5mg/kg的剂量每三周静脉注射一次，在前八个周期中联合用药，随后继续作为单一药物治疗。主要终点是由独立审查委员会评估的无进展生存期（PFS），次要终点包括总生存期（OS）、缓解持续时间（DOR）以及通过下一代测序评估的微小残留病（MRD）阴性率。

Other secondary endpoints include overall response rate (ORR), safety, and patient reported and quality of life outcomes. .

其他次要终点包括总缓解率（ORR）、安全性以及患者报告和生活质量结果。

PFS results were presented at the American Society of Clinical Oncology (ASCO) Plenary Series in February 2024 and published in the

无进展生存期（PFS）结果于2024年2月在美国临床肿瘤学会（ASCO）全体会议系列上公布，并发表在

New England Journal of Medicine

新英格兰医学杂志

. OS results were presented at the American Society of Hematology (ASH) Annual Meeting in December 2024.

操作系统结果在2024年12月的美国血液学会（ASH）年会上公布。

2,4

2，4

About DREAMM-8

关于DREAMM-8

DREAMM-8 is a multicentre, open-label, randomised phase III clinical trial evaluating the efficacy and safety of belantamab mafodotin in combination with pomalidomide plus dexamethasone (BPd) compared to bortezomib and pomalidomide plus dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma previously treated with at least one prior line of multiple myeloma therapy, including a lenalidomide-containing regimen, and who have documented disease progression during or after their most recent therapy.

DREAMM-8 是一项多中心、开放标签、随机的 III 期临床试验，评估 belantamab mafodotin 联合泊马度胺和地塞米松（BPd）对比硼替佐米和泊马度胺加地塞米松（PVd）在既往至少接受过一种多发性骨髓瘤治疗方案（包括含来那度胺的方案）并在最近一次治疗期间或之后有疾病进展记录的复发或难治性多发性骨髓瘤患者中的疗效和安全性。

The trial included 302 participants who were randomised 1:1 to receive either BPd or PVd. Compared to the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 were more heavily pre-treated in that all had prior exposure to lenalidomide, 78% were refractory to lenalidomide, 25% had prior daratumumab exposure and of those most were daratumumab refractory.

试验包括302名参与者，他们以1:1的比例随机分配接受BPd或PVd治疗。与DREAMM-7试验中研究的患者群体相比，DREAMM-8试验中的患者接受了更深入的前期治疗，所有人均曾接触过来那度胺，78%对来那度胺耐药，25%曾接触过达拉图单抗，其中大多数对达拉图单抗耐药。

Belantamab mafodotin was administered at a dose of 2.5mg/kg intravenously for the first cycle and then 1.9mg/kg intravenously every four weeks. The primary endpoint was PFS as per an independent review committee, with key secondary endpoints including OS and MRD negativity rate as assessed by next-generation sequencing.

Belantamab mafodotin在第一个周期以2.5mg/kg的剂量静脉注射，然后每四周以1.9mg/kg的剂量静脉注射。主要终点是由独立审查委员会评估的PFS，关键的次要终点包括由下一代测序评估的OS和MRD阴性率。

Other secondary endpoints include ORR, DOR, safety, and patient reported and quality of life outcomes. .

其他次要终点包括ORR、DOR、安全性以及患者报告和生活质量结果。

Results were first presented at the 2024 ASCO Annual Meeting and published in the

结果首次在2024年ASCO年会上公布，并发表在

New England Journal of Medicine

新英格兰医学杂志

.

。

3

3

Updated PFS results were presented at the European Hematology Association (EHA) Congress in June 2025.

更新的PFS结果在2025年6月的欧洲血液学协会（EHA）大会上公布。

15

15

GSK in oncology

葛兰素史克在肿瘤学领域

Our ambition in oncology is to help increase overall quality of life, maximise survival and change the course of disease, expanding from our current focus on blood and women’s cancers into lung and gastrointestinal cancers, as well as other solid tumours. This includes accelerating priority programmes such as antibody-drug conjugates targeting B7-H3 and B7-H4, and IDRX-42, a highly selective KIT tyrosine kinase inhibitor..

我们在肿瘤学领域的雄心是帮助提高整体生活质量，延长生存期并改变疾病进程，从目前专注于血液和女性癌症扩展到肺癌、胃肠道癌症以及其他实体瘤。这包括加速推进重点计划，例如靶向B7-H3和B7-H4的抗体药物偶联物，以及高选择性KIT酪氨酸激酶抑制剂IDRX-42。

About GSK

关于GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

GSK是一家全球生物制药公司，致力于联合科学、技术和人才，共同战胜疾病。欲了解更多信息，请访问gsk.com。

Cautionary statement regarding forward-looking statements

关于前瞻性陈述的谨慎声明

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q1 Results for 2025..

GSK提醒投资者，GSK所做的任何前瞻性声明或预测，包括本公告中所包含的内容，均受可能致使实际结果与预测结果存在重大差异的风险和不确定性影响。这些因素包括但不限于GSK 2024年Form 20-F年度报告中“风险因素”部分以及GSK 2025年第一季度业绩报告中描述的内容。

References

参考文献

Nooka AK, Kastritis E, Dimopoulos MA, et al. Treatment options for relapsed and refractory multiple myeloma. Blood. 2015 May 14;125(20). doi:10.1182/blood-2014-11-568923.

Nooka AK, Kastritis E, Dimopoulos MA, 等。复发性和难治性多发性骨髓瘤的治疗选择。《血液》。2015年5月14日；125(20)。doi:10.1182/blood-2014-11-568923。

Hungria V, Robak P, Hus M, et al. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):393-407. doi: 10.1056/NEJMoa2405090. Epub 2024 Jun 1. PMID: 38828933.

匈牙利 V, 罗巴克 P, 胡斯 M, 等。Belantamab Mafodotin、硼替佐米和地塞米松治疗多发性骨髓瘤。《新英格兰医学杂志》。2024年8月1日；391(5):393-407。doi: 10.1056/NEJMoa2405090。电子版发布于2024年6月1日。PMID: 38828933。

Dimopoulos MA, Beksac M, Pour L, Delimpasi S et al. Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma. N Engl J Med. 2024 Aug 1;391(5):408-421. doi: 10.1056/NEJMoa2403407. Epub 2024 Jun 2. PMID: 38828951.

Dimopoulos MA, Beksac M, Pour L, Delimpasi S 等。Belantamab Mafodotin、泊马度胺和地塞米松治疗多发性骨髓瘤。《新英格兰医学杂志》。2024年8月1日；391(5):408-421。doi: 10.1056/NEJMoa2403407。电子版发表于2024年6月2日。PMID: 38828951。

Hungria V, Robak P, H Marek, et al. Belantamab Mafodotin, Bortezomib, and Dexamethasone Vs Daratumumab, Bortezomib, and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Overall Survival Analysis and Updated Efficacy Outcomes of the Phase 3 Dreamm-7 Trial. Presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

匈牙利V，罗巴克P，马雷克H，等。Belantamab Mafodotin、硼替佐米和地塞米松 vs 达拉图单抗、硼替佐米和地塞米松治疗复发/难治性多发性骨髓瘤：3期Dreamm-7试验的总生存分析和更新的有效性结果。在第66届美国血液学会（ASH）年会及展览会上发表。

December 2024..

2024年12月。。

Global Cancer Observatory. International Agency for Research on Cancer. World Health Organization. Multiple Myeloma fact sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf. Accessed 5 March 2025.

全球癌症观察站。国际癌症研究机构。世界卫生组织。多发性骨髓瘤事实表。可访问：https://gco.iarc.who.int/media/globocan/factsheets/cancers/35-multiple-myeloma-fact-sheet.pdf。引用日期：2025年3月5日。

GSK press release issued 17 April 2025. Blenrep (belantamab mafodotin) combinations approved by UK MHRA in relapsed/refractory multiple myeloma. Available at https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-by-uk-mhra-in-relapsedrefractory-multiple-myeloma/..

GSK于2025年4月17日发布的新闻稿。Blenrep（belantamab mafodotin）联合疗法获英国药品和健康产品管理局（MHRA）批准，用于治疗复发/难治性多发性骨髓瘤。详情请见 https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-by-uk-mhra-in-relapsedrefractory-multiple-myeloma/。

GSK press release issued 19 May 2025. Blenrep (belantamab mafodotin) combinations approved in Japan for treatment of relapsed/refractory multiple myeloma. Available at https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-japan/.

GSK于2025年5月19日发布的新闻稿。Blenrep（belantamab mafodotin）联合疗法在日本获准用于治疗复发/难治性多发性骨髓瘤。详情请见 https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-japan/。

GSK press release issued 25 November 2024. Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma. Available at: https://www.gsk.com/en-gb/media/press-releases/blenrep-combinations-accepted-for-review-by-the-us-fda-for-the-treatment-of-relapsedrefractory-multiple-myeloma/..

GSK于2024年11月25日发布的新闻稿。Blenrep联合疗法已被美国FDA接受审查，用于治疗复发/难治性多发性骨髓瘤。详情请见：https://www.gsk.com/en-gb/media/press-releases/blenrep-combinations-accepted-for-review-by-the-us-fda-for-the-treatment-of-relapsedrefractory-multiple-myeloma/。

GSK press release issued 9 December 2024. Blenrep (belantamab mafodotin) combination accepted for priority review in China in relapsed/refractory multiple myeloma. Available at: https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple-myeloma/..

GSK于2024年12月9日发布的新闻稿。Blenrep（belantamab mafodotin）联合疗法在中国获受理，进入优先审评，用于治疗复发/难治性多发性骨髓瘤。可用链接：https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combination-accepted-for-priority-review-in-china-in-relapsedrefractory-multiple-myeloma/。

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Sung H、Ferlay J、Siegel R 等。全球癌症统计2020：GLOBOCAN 对185个国家36种癌症的全球发病率和死亡率估计。《CA：临床肿瘤学杂志》。2021；71（3）：209-249。doi:10.3322/caac.21660。

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Kazandjian D. 多发性骨髓瘤的流行病学及生存率：一种独特的恶性肿瘤。《肿瘤学研讨会》。2016;43(6):676–681。doi: 10.1053/j.seminoncol.2016.11.004。

Gajra A, Zalenski A, Sannareddy A, et al. Barriers to Chimeric Antigen Receptor T-Cell (CAR-T) Therapies in Clinical Practice. Pharmaceut Med. 2022 Jun;36(3):163-171. doi: 10.1007/s40290-022-00428-w. Epub 2022 Jun 7.

Gajra A，Zalenski A，Sannareddy A，等。嵌合抗原受体T细胞（CAR-T）疗法在临床实践中的障碍。《医药学杂志》。2022年6月；36(3):163-171。doi: 10.1007/s40290-022-00428-w。电子版发布于2022年6月7日。

Crombie J, Graff T, Falchi L, et al. Consensus recommendations on the management of toxicity associated with CD3×CD20 bispecific antibody therapy. Blood (2024) 143 (16): 1565–1575. doi: 10.1182/blood.2023022432.

克罗姆比 J、格拉夫 T、法尔奇 L 等。关于管理与 CD3×CD20 双特异性抗体治疗相关的毒性的共识建议。《血液》（2024）143（16）：1565–1575。doi: 10.1182/blood.2023022432。

European Medicines Agency. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep-0. Accessed 8 July 2025.

欧洲药品管理局。网址：https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep-0。访问日期：2025年7月8日。

Dimopoulos MA, Beksac M, Pour L, et al. Updated results from phase 3 DREAMM-8 study of Belantamab Mafodotin, Pomalidomide and Dexamethasone versus Pomalidomide plus Bortezomib and Dexamethasone in relapsed/refractory multiple myeloma. HemaSphere | 2025;9(S1) 846 EHA 2025 Congress.

Dimopoulos MA, Beksac M, Pour L, 等。Belantamab Mafodotin、泊马度胺和地塞米松对比泊马度胺联合硼替佐米和地塞米松治疗复发/难治性多发性骨髓瘤的3期DREAMM-8研究更新结果。HemaSphere | 2025;9(S1) 846 EHA 2025大会。