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更新于：2025-07-19

Bortezomib

硼替佐米

更新于：2025-07-19

概要

基本信息

药物类型

小分子化药

别名

[(1R)-3-methyl-1-({(2S)-3-phenyl-2-[(pyrazin-2-ylcarbonyl)amino]propanoyl}amino)butyl]boronic acid、Bortezomib (JAN/USAN/INN)、N-[(1R)-1-(DIHYDROXYBORYL)-3-methylbutyl]-N-(pyrazin-2-ylcarbonyl)-L-phenylalaninamide

+ [16]

靶点

Proteasome

作用方式

抑制剂

作用机制

蛋白酶体抑制剂

治疗领域

肿瘤免疫系统疾病心血管疾病+ [4]

在研适应症

免疫球蛋白轻链淀粉样变性巨球蛋白血症套细胞淋巴瘤+ [18]

非在研适应症

急性胸部综合征急性移植物抗宿主病急性肾损伤+ [104]

原研机构

Millennium Pharmaceuticals, Inc.

在研机构

Celgene Corp.Janssen-Cilag International NVJanssen-Cilag Ltd.

+ [21]

非在研机构

Fresenius Kabi USA LLCJohnson & Johnson Pharmaceutical Research & Development LLC

Novartis AG

+ [33]

权益机构

Shilpa Medicare Ltd.Amneal Intermediate, Inc.

Takeda Pharmaceutical Co., Ltd.

+ [4]

最高研发阶段批准上市

首次获批日期

美国 (2003-05-13),

多发性骨髓瘤

最高研发阶段(中国)临床3期

特殊审评加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (日本)

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结构/序列

分子式C19H25BN4O4

InChIKeyGXJABQQUPOEUTA-RDJZCZTQSA-N

CAS号179324-69-7

关联

1,099

项与硼替佐米相关的临床试验

NCT06015750

/ Not yet recruiting临床4期

An Interventional, Prospective Open-Label Study of Immunosuppressive Therapies to Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ?) for Hypophosphatasia (RESTORE)

The primary objective of this study is to evaluate the effect of immunosuppressive therapy (IST) in participants treated with asfotase alfa who demonstrate immune-mediated loss of effectiveness (LoE).

开始日期2025-11-19

申办/合作机构

Alexion Pharmaceuticals, Inc.

NCT06348147

/ Suspended临床2期

An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell Transplantation

This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists.
This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing.

开始日期2025-08-01

申办/合作机构

Lineberger Comprehensive Cancer Center

NCT06918002

/ Recruiting临床3期IIT

A Phase 3, Open-label, Controlled, Randomized Study of Newly Diagnosed Multiple Myeloma Treatment, Designed to Evaluate the Efficacy and Safety of the Elranatamab-lenalidomide Combination as a Replacement for Chemotherapy Followed by Autologous Stem Cell Transplant in the Consolidation Phase, and to Compare Elranatamab With Standard of Care in the Maintenance Phase

This study is designed as a multicenter, randomized, parallel groups, open-label, phase 3 study in subjects with untreated newly diagnoses Multiple Myeloma eligible for ASCT.
824 patients will be enrolled in this study from approximately 70 study sites.
The 2 parts in the Treatment Phase are described below.
Part 1: Induction/ASCT/Consolidation Phase (1:1 Randomization)
After the screening period, patients will be randomly allocated (1:1) to either:
* Arm A (standard of care arm): standard induction therapy with 4 cycles of D-VRd, followed by HDCT (Melphalan) + ASCT, D-VRd consolidation therapy
* Arm B (experimental arm): standard induction therapy with 4 cycles of D-VRd, followed by elranatamab and lenalidomide consolidation therapy.
Part 2: Maintenance Phase (1:1 Re-randomization) Patients will be re-randomized (1:1) and will enter the Maintenance Phase upon completion of consolidation therapy.
* Arm C (standard of care arm): lenalidomide
* Arm D (experimental arm): elranatamab

开始日期2025-07-09

申办/合作机构

Intergroupe Francophone du Myelome

[+1]

100 项与硼替佐米相关的临床结果

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100 项与硼替佐米相关的转化医学

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100 项与硼替佐米相关的专利（医药）

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15,767

项与硼替佐米相关的文献（医药）

2025-12-31·Journal of Oral Microbiology

Correlation of tongue coating thickness with microinflammatory state and oral microbiome in maintenance hemodialysis patients

Article

作者: Wu, Mengqi ; Lu, Bin ; Zhang, Aiping ; Zhu, Fenggui ; Liu, Hong ; Lin, Riyang ; Zhu, Yanqin ; Zeng, Xueyan

Aim:

This study investigated the correlation between tongue coating thickness (TCT), micro-inflammatory state (MIS), and oral microbiome in maintenance hemodialysis (MHD) patients.

Methods:

Forty MHD patients (20 thin-tongue coating [BTZ], 20 thick-tongue coating [HTZ]) and 15 healthy controls (DZZ) were enrolled. Blood microinflammatory markers were analyzed in all patients. Saliva samples from 15 HTZ, 15 BTZ, and 15 DZZ underwent 16S rRNA sequencing.

Results:

HTZ patients exhibited higher microinflammatory marker levels than BTZ. Oral microbiome species richness in DZZ surpassed that of the MHD groups, with distinct structural differences, particularly between HTZ and DZZ. HTZ showed higher abundances of Actinobacillus, Peptostreptococcus, and Lachnospiraceae NK4A136 group than BTZ. Correlation analysis revealed a positive correlation between the levels of IL-6 and TNF-α and the abundance of Fusobacterium, but a negative correlation with Streptococcus. Additionally, the TNF-α level positively correlated with Campylobacter.

Conclusion:

Thick tongue coating in MHD patients is associated with elevated microinflammation and altered oral microbiome, suggesting a link between inflammation and microbial dysbiosis.

2025-12-31·Hematology

Bortezomib, thalidomide, and dexamethasone versus bortezomib, lenalidomide, and dexamethasone in transplant-eligible newly diagnosed multiple myeloma: a systemic review and meta-analysis

Review

作者: Lin, Cheng-Hsien ; Teng, Chieh-Lin Jerry ; Su, Yu-Chen ; Wang, Yin-Che

BACKGROUND:

The current study aimed to compare treatment responses, the incidence of the need for auto-HSCT, and the occurrence of specific adverse events (AEs) between VTD and velcade, VRD induction regimens in patients with transplant-eligible newly diagnosed multiple myeloma (NDMM).

METHODS:

This systematic review and meta-analysis included 15 studies: six evaluating the VTD regimen and nine evaluating the VRD one. The primary endpoints were response rates after induction therapy and the incidence of a need for autologous hematopoietic stem cell transplantion (auto-HSCT) between the groups. We also examined the occurrence of grade 3 or 4 hematological, infection, and thrombotic AEs in both groups.

RESULTS:

The VTD group showed an overall response rate (ORR) of 93%, while the VRD group had an ORR of 86%. The very good partial response (VGPR) rates were 61% in the VTD group and 60% in the VRD one. The auto-HSCT rate was higher in the VTD group, averaging 93% compared to 70% in the VRD one. The incidence of grade 3 or 4 hematological AEs was 31% for VTD and 33% for VRD. The rates of grade 3 or 4 infection-related AEs were 9% in the VTD group and 14% in the VRD one. The incidence of grade 3 or 4 thrombotic AEs was 4% for VTD and 3% for VRD.

CONCLUSIONS:

With comparable safety profiles, VTD and VRD induction therapies are similarly effective for transplant-eligible NDMM, showing similar ORRs and VGPR rates.

2025-12-31·RENAL FAILURE

Outcomes of BTD vs. BCD as initial treatment of renal amyloid light-chain amyloidosis: a retrospective cohort study in China

Article

作者: He, Weiting ; Liao, Pengjun ; Li, Liwen ; Xie, Jianteng ; Zhu, Yaxi ; Yau, Hok-him ; Chen, Xiaojie ; Liu, Hui ; Wang, Wenjian ; Zhang, Yifan ; Zhang, Shaogui ; Li, Sheng ; Zhong, Liye

OBJECTIVES:

To compare the efficacy and safety of bortezomib with thalidomide and dexamethasone (BTD) and bortezomib with cyclophosphamide and dexamethasone (BCD) as the initial treatment for renal amyloid light chain (AL) amyloidosis in Chinese cohort.

METHODS:

A cohort of 174 patients with AL amyloidosis was studied in Guangdong Provincial People's Hospital from January 2008 to August 2023. Propensity-score matching cases were applied to assess the outcomes of patients treated with BTD and BCD regimen. Primary outcomes were patients achieving hematologic response and organ responses, and the secondary endpoints were patients progressing to end-stage renal disease or all-cause death.

RESULTS:

44 Patients were included. The hematologic complete response rate (CR) in the BTD group was comparable between the groups of BTD group and BCD. However, the time to achieve hematologic CR was significantly shorter in the BTD group compared to the BCD group (4.97 vs. 7.71 mon, p = 0.010). Furthermore, when reaching hematologic response, the cumulative dose of bortezomib that standardized by body surface area (BSA) was lower in BTD group than in the BCD group (10.4 vs. 15.6 mg/m², p = 0.013). There was no significant difference of renal and cardiac response between groups. However, post-treatment proteinuria levels after treatment were significantly lower in the BTD group compared to those in the BCD group (747 mg/24h vs. 2928 mg/24h, p = 0.048).

CONCLUSIONS:

Compared to BCD regimen for renal AL amyloidosis, initial treatment with BTD regimen demonstrated similar rates of hematologic CR but showed superior reduction in proteinuria, reduced cumulative dose of bortezomib and faster time-to-response.

926

项与硼替佐米相关的新闻（医药）

2025-07-18

·BioSpace

GSK’s Blenrep Loses Adcomm Vote, Further Clouding Comeback Bid

iStock, Andrii Yalanskyi The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug conjugate in multiple myeloma. The FDA’s external cancer advisors found that the benefits of GSK’s antibody-drug conjugate Blenrep to patients with relapsed or refractory multiple myeloma do not outweigh its risks. The Oncologic Drugs Advisory Committee convened Thursday to vote on two proposed Blenrep combo regimens. With a 7–1 split, the panel agreed that Blenrep plus the chemotherapy pomalidomide and steroid dexamethasone had an unfavorable benefit-risk pro this indication, while they voted 5–3 against the combination of Blenrep with bortezomib, another chemotherapy, and dexamethasone. “The efficacy data were strong but the toxicity data were also very strong,” Neil Vasan, assistant professor at the Columbia University Medical Center, said in explaining his two no votes. “I really think this was just a missed opportunity over the course of many years of development of this drug to explore these different dosages.” In a briefing document released ahead of the meeting, the FDA’s internal reviewers said that GSK had not “adequately optimized” its dosing for Blenrep, as illustrated by “high rates of ocular toxicity and poor tolerability.” The FDA reviewers also flagged the “high rates of dose modifications” in both Phase III studies used by GSK to support its Blenrep application. The briefing document also pointed out that “in both trials, there was limited enrollment in the U.S., and limited enrollment of Black or African American patients and those 75 years of age and older,” noting that this may “limit applicability” of the results to U.S. patients. Daniel Spratt of Case Western Reserve University raised the same demographic issue on Thursday. “This is the United States FDA, so the proposed patient population [are] the United States patients. The clinical development program enrolled almost no patients in the United States,” he said. “It precludes any assessment of the benefit-risk pro the U.S.” Blenrep was first approved in August 2020 for patients with relapsed or refractory multiple myeloma under the regulator’s accelerated pathway but was pulled from the market in November 2022 after it failed the confirmatory Phase III DREAMM-3 trial. Last year, however, GSK began plotting Blenrep’s comeback with data from the Phase III DREAMM-7 and DREAMM-8 trials, which demonstrated progression-free survival improvements after treatment with the drug. The pharma in June 2024 even indicated that Blenrep could hit “ multi-blockbuster ” status when positioned as a second-line treatment for multiple myeloma.

临床3期上市批准抗体药物偶联物临床结果

2025-07-17

·Insight数据库

强生肿瘤迎来王炸时刻

经过十多年的发展，强生肿瘤业务终于迎来了属于自己的王炸时刻：2010 年，强生肿瘤的业绩只有区区 14.65 亿美元，仅占创新药收入的 6.5%；2024 年，肿瘤板块收入已狂飙至 207.81 亿美元，在创新药收入中的占比达到 36.4%，并首度超越自免（178.28 亿美元），成为其创新药收入的第一大来源。2025 上半年，肿瘤业务继续保持 21.1% 的高速增长，创收 119.9 亿美元，是自免收入（77 亿美元）的 1.56 倍，贡献了创新药四成的收入。数据来源：强生历年财报，Insight 数据库制图在日前的财报电话会议上，强生CEO 更是立下雄心壮志，到 2030 年要将肿瘤业务销售额提高到 500 亿美元！本文将梳理下强生在肿瘤领域的战略和布局，看看其是如何将肿瘤业务从一棵小树苗培养成了支撑公司业绩的参天大树。多发性骨髓瘤全方位布局，打造霸主地位多发性骨髓瘤（MM）管线是强生肿瘤业务的主要收入来源，24 年收入 131 亿美元。今年上半年，MM 管线继续保持增长趋势，创收 80.93 亿美元，贡献了全部肿瘤收入的 67%。在 MM 领域，强生构建了强大且丰富的产品管线，药物类型包括化药、单抗、CAR-T、双抗，治疗范围可覆盖从末线到一线的患者群体，已成为 MM 领域的霸主。硼替佐米：MM 领域的第一桶金强生在多发性骨髓瘤领域的布局始于硼替佐米。硼替佐米是一种蛋白酶体抑制剂，最初由 Millennium Pharmaceuticals 开发。2003 年强生通过一项超 5.35 亿美元的合作，获得在美国以外地区开发和商业化硼替佐米的权益。2008 年，Millennium 被武田以 88 亿美元收购，硼替佐米随之由武田和强生在全球范围内共同开发和商业化。硼替佐米于 2003 年 5 月首次在美国首批，用于 MM 三线或末线治疗，是当时 MM 领域十多年中首个获 FDA 批准的新药。在 MM 领域，硼替佐米很快完成了从后线到前线的推进，获批适应症包括单药和联合用药，并成为 MM 患者临床治疗的一线用药。在套细胞淋巴瘤适应症上，硼替佐米的治疗地位也由二线前移至一线。根据强生财报，2008-2020 年之间，硼替佐米累计卖了近 148 亿美元，加上 2007 年之前和 2021 年之后未披露的销售额，该药为强生带来的总收入预计超过 150 亿美元。随着专利到期，硼替佐米销售额直线下滑，其到 2020 年的销售额（强生侧）已只有 4.08 亿美元。不过，强生早有对策。硼替佐米历年销售额图片来源：Insight 数据库达雷妥尤单抗：王炸产品达雷妥尤单抗是硼替佐米的接棒者。它最初由 Genmab 开发。强生在 2012 年 8 月以 5500 万美元首付款获得了该药的全球独家权利。由于在 MM 治疗中效果突出，达雷妥尤单抗曾获得 FDA 授予快速通道资格、突破性疗法认定、优先审评资格。2015 年 11 月，达雷妥尤单抗获得 FDA 加速批准（现已转为完全获批），用于治疗四线及以上 MM 患者，并成为全球首个获批的 CD38 单抗。商业化上市第 2 年，它就创造了 12.42 亿美元的销售额，抵消了硼替佐米因专利过期出现的收入下滑情况。此后，强生加速将达雷妥尤单抗在 MM 领域的适应症从末线逐步拓展到三线、二线、一线。与此同时，为提升其市场竞争力，强生还开发了达雷妥尤单抗的皮下注射剂型。随着新适应症的拓展、皮下制剂的成功开发、获批地区的增加，达雷妥尤单抗销售额也一路狂飙。2024 年，其在上市 9 年后年销售额首次突破 100 亿美元，大卖 116.7 亿美元，靠一己之力撑起了强生肿瘤业务的半边天。2025 上半年，该药继续保持高达 21.7% 的双位数增长，创收 67.76 亿美元。达雷妥尤单抗历年销售额图片来源：Insight 数据库达雷妥尤单抗在 MM 领域的潜力尚未得到完全释放。2024 年底，皮下达雷妥尤单抗已在欧美日递交治疗高危冒烟型多发性骨髓瘤（HR-SMM）的上市申请。冒烟型多发性骨髓瘤是 MM 的无症状前驱阶段，目前尚无有效的手段来阻止高危患者的疾病进展。今年 5 月 20 日， FDA 肿瘤药物顾问委员会（ODAC）以 6:2 的投票支持达雷妥尤单抗 HR-SMM 适应症的获批。如果获批，达雷妥尤单抗将进一步覆盖 MM 的癌前市场，构建 MM 患者全线治疗的闭环。西达基奥仑赛：下一个十亿美元分子西达基奥仑赛是强生在 2017 年从传奇生物引进的一款 BCMA CAR-T 产品，引进的主要原因还是看中其在 MM 中的治疗潜力。2017 年 ASCO 大会上，西达基奥仑赛凭借在复发/难治 MM Ⅰ 期临床中的惊艳数据（ORR 100%，CR 95%），一举成为当年 ASCO 上的黑马。同年 12 月，强生和传奇达成合作共同开发和商业化西达基奥仑赛，以进一步扩充其 MM 和肿瘤管线。另一方面，2017 年是 CAR-T 元年，强生通过引进产品也可以快速切入 CAR-T 赛道。西达基奥仑赛于 2022 年首次获批，现已在欧美日中获批用于复发/难治性 MM 的末线治疗，并在美国和欧盟获批用于复发/难治性 MM 的二线治疗。今年 ASCO 上公布的 CARTITUDE-1 研究随访数据显示，复发或难治性 MM 患者的中位总生存期（OS）达到 60.7 个月，约 1/3 实现了≥5 年的无进展生存，效果非常好。2024 年，西达基奥仑赛全球销售额为 9.63 亿美元。2025 上半年，西达基奥仑赛创收 8.08 亿美元，其将成为强生肿瘤管线中又一款重磅炸弹。西达基奥仑赛销售额图片来源：Insight 数据库双抗：新生力量尽管新进上市的西达基奥仑赛疗效显著，强生还是为其 MM 管线打造了两款双抗——特立妥单抗和塔奎妥单抗，这两款产品都是从其「老搭档」Genmab 引进的。与 CAR-T 需要个体化定制生产相比，双抗可以批量化生产，更加方便。特立妥单抗于 2022 年 8 月首次获批，现已在欧美中日获批用于多发性骨髓瘤末线治疗，是全球首个获批的 BCMA×CD3 双抗，24 年卖了 5.49 亿美元。今年上半年，特立妥单抗创收 3.17 亿美元，同比增长 18.2%。塔奎妥单抗在 2023 年 8 月首次在美国获批，用于多发性骨髓瘤末线治疗，是全球首款 GPRC5D×CD3 双抗，其可以给接受 BCMA CAR-T 或者 BCMA×CD3 双抗治疗后出现进展的患者提供一种新的选择。今年上半年，该药实现 53% 的高速增长，创收 1.92 亿美元。重磅炸弹：‌伊布替尼在血液瘤领域，强生还打造了一款重磅炸弹产品——‌伊布替尼（Imbruvica）。 ‌伊布替尼是强生从 Pharmacyclics（后被艾伯维收购）引进的 BTK 抑制剂，是强生血液肿瘤领域的第 2 款产品。‌伊布替尼于 2014 年首次获批，是全球首个获批上市的 BTK 抑制剂，获批适应症涵盖慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL，二线/一线）、套细胞淋巴瘤（二线）、华氏巨球蛋白血症、移植物抗宿主病。自上市以来，‌伊布替尼累计为强生贡献了超过 300 亿美元的收入。不过，随着专利到期，‌伊布替尼的销售额从 2022 年已开始出现下滑，24 年的销售额为 30.38 亿美元。今年上半年，其销售额继续下跌 7% 至 14.14 亿美元。图片来源：Insight 数据库实体瘤领域前列腺癌管线是现金牛强生在实体瘤领域的收入主要来自于两款前列腺癌治疗产品——阿比特龙和阿帕他胺，这两款产品累计为强生贡献了约 381.49 亿美元的收入。阿比特龙是一种选择性、不可逆的 CYP17A1 酶抑制剂，最初由 Cougar Biotechnology 研发，强生在 2009 年通过收购 Cougar 公司获得该产品。该药在 2011 年首次获批，用于去势抵抗性前列腺癌二线治疗，随后又拓展至一线治疗。截至 2025 上半年，阿比特龙已累计创造了超 268 亿美元的收入。随着专利已到期，阿比特龙的年销售额已由高峰期的 34.98 亿美元下滑至 24 年的 6.31 亿美元。今年上半年，其销售已只有 2.7 亿美元，同比下滑 21.7%。图片来源：Insight 数据库在阿比特龙专利过期后，强生成功推出了后继产品阿帕他胺。阿帕他胺是第二代非甾体雄激素受体（AR）抑制剂，最初由 Aragon Pharmaceuticals 开发，强生在 2013 年通过收购 Aragon 将该药纳入麾下。阿帕他胺于 2018 年首次获批，目前已在美国、欧盟、日本、中国获批，用于去势抵抗性前列腺癌和激素依赖性前列腺癌一线治疗。上市以来，阿帕他胺销售额一路上涨，24 年创收 29.99 亿美元，同比增长 25.64%，抵消了阿比特龙专利过期对业绩的影响。今年上半年，其销售额继续保持 17.8% 的高速增长，达到 16.79 亿美元。图片来源：Insight 数据库在前列腺癌领域，强生还推出了尼拉帕利+醋酸阿比特龙的复方制剂——Akeega。Akeega 于 2023 年 4 月首次获批，现已在欧盟、美国、中国上市，联合泼尼松或泼尼松龙用于治疗 BRCA1/2 突变的转移性去势抵抗性前列腺癌成人患者（mCRPC）一线治疗。目前，强生也在逐步拓展前列腺癌之外的其它实体瘤领域。在肺癌领域，强生已成功上市了埃万妥单抗和兰泽替尼。埃万妥单抗是强生从 Genmab 引进的一款 EGFR×c-MET 双抗，兰泽替尼是强生从 Yuhan Corporation 引进的一款第三代 EGFR-TKI。埃万妥单抗已获批单药或联合化疗用于 EGFR ex20ins 突变 NSCLC、与兰泽替尼联合用于 EGFR 敏感突变 NSCLC 。此外，强生还从 Astex Pharmaceuticals 引进了一款泛 FGFR 抑制剂厄达替尼，该药已在美国、欧盟、日本、中国获批用于局部晚期或转移性尿路上皮癌患者。对于塔奎妥单抗、埃万妥单抗、厄达替尼、兰泽替尼等产品，强生并未在 2024 财报中披露其具体销售额，而是归到了其它肿瘤产品中。24 年这些产品合计创造了 9.31 亿美元的收入。小结强生肿瘤业务的发家史几乎也是一部 BD 交易/并购史，这些肿瘤管线都是通过并购公司或者从外部引进而来。尤其是 Genmab 公司，先后为强生输送了达雷妥尤单抗、特立妥单抗、塔奎妥单抗、埃万妥单抗四款 first-in-class 产品。在治疗领域方面，强生非常专注，深耕 MM 领域，并在过去二十年中一步步迭代产品，药物类型非常丰富，尤其是在应对产品专利期方面做的很好，保证了业绩的连年上涨。在实体瘤领域，贡献大头还是前列腺癌产品，肺癌领域的埃万妥单抗和兰泽替尼刚获批不久，是后继增长点。对于强生而言，肿瘤业务近 208 亿美元的年收入是一个新的起点，500 亿美元的销售额将是其要攀登的下一座高峰。参考资料：[1] 强生历年财报及官方新闻稿[2]Insight 数据库封面来源：视觉中国免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：馨药PR 稿对接：微信 insightxb投稿：微信 insightxb；邮箱 insight@dxy.cn多样化功能、可溯源数据……Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

财报优先审批免疫疗法细胞疗法快速通道

2025-07-17

·Firstwordpharma

GSK's bid to revive Blenrep hits snag after negative FDA adcom

GSK's efforts to bring its multiple myeloma drug Blenrep (belantamab mafodotin) back to the US market ran into trouble Thursday, after an FDA advisory panel voted against two proposed combination regimens due to ongoing concerns about the drug's eye-related side effects and dosing.The Oncologic Drugs Advisory Committee (ODAC) voted 5-3 against the benefit-risk profile of Blenrep when combined with bortezomib and dexamethasone at the proposed dose and in the target patient population, which is adults who have received at least one prior line of therapy. A similar second vote on the combination of Blenrep with BMS's Pomalyst (pomalidomide) and dexamethasone yielded an even more decisive 7-1 rejection.The votes followed the release of FDA briefing documents earlier this week that flagged Blenrep's "unique" eye toxicity, including changes in the corneal epithelium, visual acuity changes, and other ocular symptoms, such as blurred vision and dry eye.Agency scientists also questioned whether GSK had truly identified the best dose. In both pivotal trials, DREAMM-7 and DREAMM-8, many patients needed dose modifications, and a majority of patients were not receiving the intended dosage by the third treatment cycle. FDA staff noted that the only way to manage the side effects was by adjusting dosing, a strategy they warned could be difficult to replicate in real-world clinical settings.'Missed opportunity'"This was a challenging decision because the efficacy data were strong, but the toxicity data were also very strong," said Neil Vasan, who chaired the meeting, and voted 'no' on both counts. "I took a textualist interpretation to [the voting questions] – and I'd like to emphasise the words 'at the proposed dosage.' This was for me the what swayed the decision."In remarks prior to the votes, Vasan said many ODAC participants saw the programme as a "missed opportunity, at multiple levels; missed opportunity from conversations years back when this drug was first developed, a missed opportunity from the initial Phase I data to explore all dosages, a missed opportunity at the Phase III level to perhaps explore more dosages at the RCT level." Panel member Grzegorz Nowakowski said this was probably "one of the most difficult votes" he's cast as an ODAC committee member. He voted 'yes' on the first question and 'no' on the second."On one hand, from a regulatory perspective, the whole drug development programme probably made all the possible mistakes which could have happened, including the lack of US representation in the pivotal studies, and also the lack of the early dose optimisation, which could avoid a lot of the toxicity discussion which you had here," Nowakowski said. "On the other hand, I'm also a practising haematologist and, you know, the drug is clearly active."FDA decision next weekBlenrep was originally greenlit under accelerated approval in 2020 as a fifth-line monotherapy, but the drug was withdrawn from the US market a little over two years later after failing a confirmatory trial. However, it has been staging a slow comeback, spurred by the DREAMM-7 and DREAMM-8 readouts, winning approvals in the UK and Japan this year, with an EU nod expected soon.But Thursday's negative vote casts doubt on whether the BCMA-directed antibody-drug conjugate will make its return to the US by year-end, as GSK hopes. The agency is set to make a final decision by July 23, and a rejection would deal a major blow to the company's growth growth ambitions.It also marks the second time Blenrep has faced regulatory challenges over ocular concerns (see – Spotlight On: Blenrep facing adcom déjà vu but GSK is coming prepared). The FDA previously recommended that GSK conduct further dose finding, but the company continued to pursue its proposed dose anyway, arguing that efficacy would be negatively impacted. "I think the issue was just that there was not exploration done at lower doses – even before, going back many years," commented Nicole Gormely, division director at the FDA's Division of Hematologic Malignancies.For more, see – Spotlight On: GSK's case for Blenrep's re-relevance in MM gaining purchase.

加速审批临床3期临床结果临床1期抗体药物偶联物

100 项与硼替佐米相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03150	硼替佐米	L01XX32	DB00188

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
免疫球蛋白轻链淀粉样变性	日本	Janssen Pharmaceutical KK	2006-10-20
巨球蛋白血症	日本	Janssen Pharmaceutical KK	2006-10-20
套细胞淋巴瘤	欧盟	Janssen-Cilag International NV	2004-04-26
套细胞淋巴瘤	冰岛	Janssen-Cilag International NV	2004-04-26
套细胞淋巴瘤	列支敦士登	Janssen-Cilag International NV	2004-04-26
套细胞淋巴瘤	挪威	Janssen-Cilag International NV	2004-04-26
多发性骨髓瘤	美国	Takeda Pharmaceuticals U.S.A., Inc.	2003-05-13

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
复发性弥漫性大B细胞淋巴瘤	临床3期	意大利	Janssen-Cilag Ltd.	2013-02-04
复发性弥漫性大B细胞淋巴瘤	临床3期	意大利	Janssen Pharmaceutica NV	2013-02-04
难治性弥漫性大 B 细胞淋巴瘤	临床3期	意大利	Janssen Pharmaceutica NV	2013-02-04
难治性弥漫性大 B 细胞淋巴瘤	临床3期	意大利	Janssen-Cilag Ltd.	2013-02-04
浆细胞白血病	临床3期	美国	Janssen Scientific Affairs LLC	2012-01-13
浆细胞白血病	临床3期	中国	Janssen Scientific Affairs LLC	2012-01-13
浆细胞白血病	临床3期	澳大利亚	Janssen Scientific Affairs LLC	2012-01-13
弥漫性大B细胞淋巴瘤	临床3期	瑞士	Janssen-Cilag Ltd.	2011-04-01
弥漫性大B细胞淋巴瘤	临床3期	英国	Janssen-Cilag Ltd.	2011-04-01
B细胞淋巴瘤	临床3期	美国	Millennium Pharmaceuticals, Inc.	2006-03-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04484623 (DREAMM-8, ASCO2025)	临床3期	难治性多发性骨髓瘤	302	Belantamab mafodotin plus pomalidomide and dexamethasone (BPd)	廠餘願鑰選蓋選醖鏇膚(願鑰簾餘艱衊獵構網獵) = 廠壓願鹽鑰廠繭淵製襯選憲簾醖蓋願膚齋積齋 (糧網繭顧製鏇製觸網網 ) 更多	积极	2025-05-30
				Pomalidomide, bortezomib, and dexamethasone (PVd)	廠餘願鑰選蓋選醖鏇膚(願鑰簾餘艱衊獵構網獵) = 窪壓鑰鏇窪齋淵鑰膚遞選憲簾醖蓋願膚齋積齋 (糧網繭顧製鏇製觸網網 ) 更多
NCT02773030 (CC-220-MM-001, ASCO2025)	临床1/2期	多发性骨髓瘤	18	Iberdomide, bortezomib, and dexamethasone (IberVd)	淵廠窪選衊積觸簾製膚(齋網積遞鹽憲餘壓獵鹹) = 14 (82.4%) pts had grade (Gr) 3/4 treatment-emergent AEs (TEAEs); primarily infections (47.1%), including pneumonia (17.6%) and COVID-19 (11.8%) 衊製顧鬱鬱積築淵膚網 (構積鬱觸獵製夢積觸廠 ) 更多	积极	2025-05-30
NCT02773030 (CC-220-MM-001, EHA2025)	临床1/2期	多发性骨髓瘤	18	Iberdomide	遞窪構鹹鏇衊膚夢夢廠(窪窪襯遞構壓餘夢衊襯) = 14 (82.4%) pts had grade (Gr) 3/4 treatment-emergent AEs (TEAEs); primarily infections (47.1%), including pneumonia (17.6%) and COVID-19 (11.8%) 蓋獵窪範範艱膚選顧憲 (淵簾積製鹽餘製觸鑰鏇 ) 更多	积极	2025-05-22
NCT04181827 (CARTITUDE-4, CTgov)	临床3期	复发性多发性骨髓瘤 \| 多发性骨髓瘤	419	daratumumab+pomalidomide+bortezomib+dexamethasone (DPd) (Arm A: Standard Therapy: PVd or DPd)	獵觸顧膚廠鹹願觸鹽餘(夢願選簾衊範願鏇艱膚) = 醖餘糧鏇鬱鏇選夢築醖鹹願窪鑰網選糧憲憲鹹 (膚鏇範糧窪膚願繭艱膚, 窪衊壓構憲積選齋積窪 ~ 廠醖淵築憲築鬱壓壓選) 更多	-	2025-05-20
				Autoleucel [Cilta-cel]+JNJ-68284528 (Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]))	獵觸顧膚廠鹹願觸鹽餘(夢願選簾衊範願鏇艱膚) = 鹹窪餘遞鬱艱膚築糧醖鹹願窪鑰網選糧憲憲鹹 (膚鏇範糧窪膚願繭艱膚, 範範觸壓鏇憲膚夢獵選 ~ 鑰獵繭淵遞製願鬱夢窪) 更多
PB3032 (EHA2025)	N/A	多发性骨髓瘤一线 \| 巩固 ISS stage III \| high β2-microglobulin \| elevated LDH ... 更多	73	VTD regimen (Bortezomib, Thalidomide, Dexamethasone)	齋糧築觸醖壓醖遞顧簾(衊艱鏇憲築蓋壓範積襯) = 6% 繭齋遞構艱鏇繭願觸蓋 (淵襯衊廠鏇襯鹽網窪餘 ) 更多	-	2025-05-14
				Bortezomib (Autologous stem cell transplantation)
NCT05147493 (EAE116, EHA2025)	临床2期	多发性骨髓瘤 \| 肾功能不全	51	Isatuximab 10mg/kg	窪淵憲襯觸蓋衊製鏇糧(夢積淵繭醖願窪鹽襯積) = 11 (21.6%) with a fatal adverse event 夢糧遞積積齋夢範艱壓 (觸遞獵齋醖廠選襯遞衊 ) 更多	-	2025-05-14
PS1460 (EHA2025)	N/A	骨髓单体7 EZH2	72	Bortezomib (EZH2 deletion)	齋選窪網鬱蓋選積齋網(壓壓窪鏇鹽壓醖壓簾構) = 願鹹鏇鏇繭壓艱鏇衊夢窪鏇積襯範醖廠膚憲願 (選鹽憲遞顧鏇積鬱觸簾 ) 更多	-	2025-05-14
				Bortezomib (No EZH2 deletion)	齋選窪網鬱蓋選積齋網(壓壓窪鏇鹽壓醖壓簾構) = 膚簾遞鏇積廠襯艱憲願窪鏇積襯範醖廠膚憲願 (選鹽憲遞顧鏇積鬱觸簾 ) 更多
PB2995 (EHA2025)	临床2期	多发性骨髓瘤维持	22	Daratumumab	鹽蓋憲繭簾廠鹹構遞構(積膚鏇衊繭淵壓鹽憲蓋) = 憲積選淵網鑰願膚繭鹹衊廠醖鹽構網憲醖觸壓 (遞鹹艱鏇觸繭築醖餘衊 ) 更多	积极	2025-05-14
				Bortezomib	鹽蓋憲繭簾廠鹹構遞構(積膚鏇衊繭淵壓鹽憲蓋) = 鑰醖鬱鬱襯積蓋製獵積衊廠醖鹽構網憲醖觸壓 (遞鹹艱鏇觸繭築醖餘衊 )
EUMELEIA PHASE 2 (EHA2025)	临床2期	浆细胞白血病维持	20	D-PAD/D-CVD + Daratumumab	糧膚窪醖選壓製構簾鹹(窪築蓋願遞鹹膚襯網顧) = One patient died 30 days post-baseline from respiratory tract infection (unrelated to treatment) 範範憲顧淵夢淵製築積 (醖襯襯襯夢範鹽製糧鬱 ) 更多	-	2025-05-14
PB3020 (EHA2025)	N/A	多发性骨髓瘤	12	Selinexor	範醖鹽夢築鑰願鹹選壓(獵糧夢膚艱艱鬱選齋窪) = Common AEs included nausea (11/12), vomiting (10/12), and cytopenia (10/12). Four patients discontinued treatment due to intolerable AEs. 願憲製鹹繭構廠築鏇衊 (齋鏇餘膚糧簾餘鏇窪範 ) 更多	积极	2025-05-14
				Bendamustine