预约演示

更新于：2025-09-03

Bevacizumab

贝伐珠单抗

更新于：2025-09-03

概要

基本信息

药物类型

单克隆抗体

别名

Bevacizumab(Genetical Recombination)、rhuMAb-VEGF、贝伐单抗

+ [17]

靶点

VEGF-A

作用方式

抑制剂

作用机制

VEGF-A抑制剂(血管内皮生长因子A抑制剂)、血管生成抑制剂

治疗领域

肿瘤神经系统疾病消化系统疾病+ [11]

在研适应症

不可切除的肝细胞癌肝细胞癌复发性胶质母细胞瘤+ [216]

非在研适应症

异戊酸血症急性嗜碱性粒细胞白血病急性嗜酸细胞白血病+ [283]

原研机构

Genentech, Inc.

在研机构

National Cancer InstituteRoche Registration GmbHHoffmann-La Roche, Inc.

+ [26]

非在研机构

Roswell Park Comprehensive Cancer Center

The University of California, San Francisco

Celgene Corp.

+ [52]

权益机构

Roche Korea Co., Ltd.

Immune-Onc Therapeutics, Inc.

Roche Holding AG

+ [5]

最高研发阶段批准上市

首次获批日期

美国 (2004-02-26),

结肠癌直肠癌

最高研发阶段(中国)批准上市

特殊审评突破性疗法 (美国)、孤儿药 (美国)、加速批准 (美国)

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结构/序列

Sequence Code 41632H

来源: *****

Sequence Code 41637L

来源: *****

关联

3,326

项与贝伐珠单抗相关的临床试验

NCT06696768

/ Recruiting临床1期IIT

Phase I Clinical Trial of CA-4948 (Emavusertib) in Combination With FOLFOX Plus Bevacizumab as Frontline Treatment in Patients With Metastatic Colorectal Cancer

This phase I trial studies the side effects and best dose of CA-4948 when given together with fluorouracil, leucovorin, oxaliplatin (FOLFOX) plus bevacizumab in treating patients with colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). CA-4948 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The chemotherapy drugs used in FOLOX, fluorouracil and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin is used with fluorouracil to treat colorectal cancer. Bevacizumab is in a class of medications called anti-angiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to the tumor. This may slow the growth and spread of the tumor. Giving CA-4948 with FOLFOX plus bevacizumab may be safe, tolerable and/or effective in treating patients with metastatic colorectal cancer.

开始日期2026-01-23

申办/合作机构

National Cancer Institute

NCT05375708

/ Suspended临床2期IIT

A Multicenter Phase II Randomized Trial to Evaluate Systemic Therapy Versus Systemic Therapy in Combination with Stereotactic Radiotherapy in Patients with Metastatic Colorectal Cancer

A small number of colorectal cancer patients with limited oligometastases may be candidates for local treatment of metastases (e.g., resection, ablation). However, it is unclear if patients with more extensive metastatic disease benefit from local therapies to control visible metastasis.
The purpose of this study is to assess the impact of stereotactic body radiation therapy (SBRT) in combination with systemic therapy compared to systemic therapy alone on safety and efficacy in patients with metastatic colorectal cancer (mCRC) and ≤10 metastases.

开始日期2025-12-01

申办/合作机构

University Medical Center of Utrecht

NCT07011550

/ Recruiting临床2期IIT

Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer

To learn if the drug combination of BMS-986340, nivolumab, trifluridine/tipiracil, and bevacizumab can help to control advanced or metastatic MSS-CRC.

开始日期2025-11-30

申办/合作机构

The University of Texas MD Anderson Cancer Center

100 项与贝伐珠单抗相关的临床结果

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100 项与贝伐珠单抗相关的转化医学

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100 项与贝伐珠单抗相关的专利（医药）

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23,216

项与贝伐珠单抗相关的文献（医药）

2026-04-01·DEN open

Long‐term results of palliative placement of very low‐axial force self‐expandable metallic stents for malignant colorectal obstruction

Article

作者: Moroi, Rintaro ; Kuwai, Toshio ; Yoshida, Shuntaro ; Enomoto, Toshiyuki ; Tomita, Masafumi ; Kyo, Rika ; Shiratori, Toshiyasu ; Saida, Yoshihisa ; Matsuzawa, Takeaki ; Isayama, Hiroyuki ; Sumida, Yorinobu ; Yamada, Tomonori ; Sasaki, Takashi

Abstract:

Objectives:

Stent placement is a standard option for palliative decompression in patients with malignant colorectal obstruction. Long‐term stent placement is associated with perforation, migration, and stent occlusion. Perforation is associated with life expectancy. Several studies have shown that stents with a high axial force (AF), which is defined as the force required to maintain the stent straight after it has bent, are associated with a higher perforation rate. Therefore, we evaluated the long‐term outcomes of using a very low AF stent (Niti‐S Enteral Colonic Uncovered stent D‐type) for palliative purposes.

Methods:

Eighty‐one consecutive patients with malignant colorectal obstruction in 33 medical institutions were evaluated. A stent with very low AF was placed using an endoscope system. We evaluated the adverse events (including perforation, migration, and stent occlusion), 1‐year survival rate, and cumulative patency rate. Univariate analysis was conducted using Fisher's exact test. The overall survival and cumulative patency rates were assessed using the Kaplan–Meier method.

Results:

The 1‐year cumulative survival rate was 37.8% after stent placement. The 3‐month, 6‐month, and 1‐year cumulative patency rates after stenting were 93.6%, 84.2%, and 75.8%, respectively. The major adverse events included stent migration (6.2%), stent occlusion (9.9%), and perforation (2.5%). Chemotherapy was administered in 26 cases (32.1%) after stenting, and bevacizumab was administered in five cases. However, no cases of perforation occurred following bevacizumab administration.

Conclusions:

Our results suggest that very low AF stents are safe and effective. Therefore, they may be a suitable option for applications, such as palliation. (UMIN 000011304)

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness analysis of regorafenib dose optimization for refractory metastatic colorectal cancer

Article

作者: Appukkuttan, Sreevalsa ; Cho, Sang Kyu ; Barzi, Afsaneh ; Grossman, Jamie ; Lee, Woojung ; Babajanyan, Svetlana ; Hocum, Brian ; Marian, Marisca ; Yang, Min ; Bekaii-Saab, Tanios

BACKGROUND:

New regimens have emerged as third-line or later therapies for metastatic colorectal cancer (mCRC), including regorafenib dose optimization (ReDO), trifluridine/tipiracil and bevacizumab (TAS-BEV) combination therapy, and fruquintinib. We evaluated relative cost-effectiveness of these therapies in patients with mCRC from a US payer's perspective.

MATERIALS AND METHODS:

A partitioned survival model (PSM) was constructed to estimate total costs and quality-adjusted life years (QALYs). Clinical parameters were obtained from pivotal trials of the respective therapies and incremental cost-effectiveness ratios (ICERs) were estimated to assess relative cost-effectiveness of these treatments. Model robustness was assessed using deterministic (DSA) and probabilistic sensitivity analysis (PSA). Three scenario analyses were conducted: (1) assuming equal efficacy across treatments, (2) with prior exposure to anti-vascular endothelial growth factor (VEGF) therapy, and (3) alternative clinical inputs for fruquintinib from a different clinical trial.

RESULTS:

Under the conventional willingness-to-pay (WTP) threshold in US ($150,000 per QALY gained), ReDO was cost-effective when compared with TAS-BEV and was dominant over fruquintinib. TAS-BEV was associated with an incremental QALY of 0.197 over ReDO, resulting in an ICER at $554,567 per QALY gained. The base case results were robust in DSA and PSA. Most influential parameters were treatment cost and effectiveness. In patients with prior anti-VEGF therapy, ReDO remained cost-effective compared to TAS-BEV and fruquintinib under the conventional WTP threshold.

LIMITATION:

Differences in trial populations may affect the comparability of the outcomes. Sensitivity and scenario analyses were conducted to address these limitations.

CONCLUSION:

ReDO was cost-effective compared with TAS-BEV from the US payer's perspective despite a higher QALY gain associated with TAS-BEV. ReDO was dominant over fruquintinib, consistently having a higher QALY gain and lower cost.

2025-12-31·JOURNAL OF MEDICAL ECONOMICS

Cost-efficiency and expanded access modeling of conversion to biosimilar bevacizumab in metastatic colorectal and non-squamous non-small cell lung cancer in Medicare

Article

作者: Bernauer, Mark ; Roth, Joshua A. ; Dorman, Stephanie ; Kratochvil, David

BACKGROUND:

Biosimilars to originator bevacizumab (Avastin), such as bevacizumab-bvzr (Zirabev), can deliver substantial savings and/or expanded access to biologic therapy for patients with metastatic colorectal (mCRC) and non-squamous non-small cell lung cancer (mNSCLC). The objective of this study is to explore the cost-efficiency and budget-neutral expanded access of bevacizumab-bvzr in mCRC and mNSCLC in Medicare.

METHODS:

We developed a Medicare payer perspective simulation model of patients treated for mCRC and mNSCLC to estimate cost-savings from converting bevacizumab (originator) to bevacizumab-bvzr or alternative biosimilars such as bevacizumab-awwb, -maly, and -abcd. The target patient population receiving annual first-line systemic therapy was calculated using Medicare enrollment data, SEER cancer incidence rates in patients age ≥65, and an assumption that 39.3% and 77.2% of new diagnoses receive systemic therapy for mCRC and mNSCLC respectively based on recent evidence. 76.0% of systemically treated mCRC patients and 11.4% of incident mNSCLC patients were expected to be treated with bevacizumab-based regimens based on recent evidence. Costs were derived from the 2024 Average Sales Price (ASP). Results include per-patient per-month (PPPM) cost savings (vs. originator), total monthly savings in the cohort, and number needed to convert (NNC) to biosimilar to fund the treatment of an additional 100 patients.

RESULTS:

PPPM savings from conversion to bevacizumab-bvzr were $4,205 in mCRC and $8,410 in mNSCLC. In 100% conversion scenarios, full cohort monthly savings were $27,664,432 in mCRC (n = 6,579) and $32,319,323 in mNSCLC (n = 3,843), respectively. At 100% conversion, monthly savings from biosimilar conversion could fund up to 13,887 additional mCRC patient-months of treatment with bevacizumab-bvzr + FOLFOX, and up to 8,959 additional mNSCLC patient-months of treatment with bevacizumab-bvzr + paclitaxel + carboplatin. In mCRC and mNSCLC the biosimilar NNC from the originator was 47 and 43, respectively. The biosimilar NNC from other biosimilars ranged from 60-4,564 and 55-4,422 for mCRC and NSCLC, respectively.

CONCLUSION:

In the first cost-efficiency and expanded access study of biosimilar bevacizumab in mCRC and mNSCLC, we find that bevacizumab-bvzr-based regimens can result in substantial cost savings relative to originator-based first line treatment in Medicare. These cost savings could be reinvested to treat a substantial number of additional patients with mCRC or mNSCLC, or fund other costs of care in Medicare, on a budget-neutral basis.

2,997

项与贝伐珠单抗相关的新闻（医药）

2025-09-03

·医学新视点

脑转移缓解率42.6%，延长生存期！JAMA子刊：中国学者带来乳腺癌治疗新方案

约80%乳腺癌为HER2阴性，HER2转移性乳腺癌患者中约15%-32%会发生脑转移，确诊脑转移后的中位总生存期（OS）仅为9~14个月。针对这类患者，颅内治疗以局部放疗为主，但会带来神经认知损伤；系统治疗仅有卡培他滨等少数选择，疗效证据匮乏。目前亟需能同时治疗颅内、颅外病灶的新方案。既往研究提示贝伐珠单抗联合化疗有潜力带来较为积极的结果。优替德隆（utidelone）是埃博霉素类衍生物和新一代微管抑制剂，此前已在中国获批治疗既往接受过至少一种化疗方案的复发或转移性乳腺癌。U-BOMB 2期试验进一步探索了优替德隆联合贝伐珠单抗治疗活动性脑转移性乳腺癌患者的效果，HER2阴性亚组患者的结果近期发表于《美国医学会杂志-肿瘤学》（JAMA Oncology）。数据显示，该联合方案可带来42.6%的颅内客观缓解率（ORR），患者中位总生存期长达15.1个月。论文通讯作者为河南省肿瘤医院闫敏博士。截图来源：JAMA Oncology 这是一项非随机试验，在中国5家中心开展，共入组47例HER2阴性转移性乳腺癌患者，其中35例为未经治疗的脑转移患者，12例为局部放疗后进展的脑转移患者。患者接受优替德隆联合贝伐珠单抗，每3周为一个周期，直至病情进展或出现不可耐受的毒性。研究团队同时采用RECIST 1.1（主要结局）和RANO-BM双标准评估颅内缓解情况，根据RECIST 1.1标准评估颅外病灶缓解情况。数据显示，优替德隆联合贝伐珠单抗可高效控制颅内病灶。在RECIST 1.1标准下，中枢神经系统（CNS）的ORR为42.6%，在RANO-BM标准下为40.4%。15例基线有脑转移症状的患者全部实现症状改善。中位CNS无进展生存期达10.6个月。6个月和12个月时的CNS PFS率分别为78.1%和33.4%。该方案也具有颅外抗肿瘤活性，在32例具有颅外可测量病灶的患者中，颅外ORR为21.9%。此外，全身中位PFS为7.7个月。患者生存期有所改善，中位OS为15.1个月，6个月OS率为89.4%，12个月OS率为60.3%。截至数据分析，2例患者在进展后接受了全脑放疗，所有47例患者的至全脑放疗的中位时间尚未达到，意味着超过半数患者尚未接受全脑放疗，优替德隆联合贝伐珠单抗可延迟脑放疗需求。研究团队在论文中指出，对于同一病灶，全剂量放射治疗通常只能进行一次。如果复发，反复放疗引起脑组织坏死的风险将显著增加。对颅内和颅外病变均有效的系统治疗方法非常重要。优替德隆联合贝伐珠单抗治疗安全可控。3级以上治疗中出现的不良事件（TEAEs）发生率为23.4%，以淋巴细胞计数减少（10.6%）和白细胞计数减少（6.4%）较为常见。未发生严重或致命的不良事件。值得注意的是，3级神经病变（PN）发生率仅2.1%，低于历史数据22%。总体而言，这些数据提示优替德隆联合贝伐珠单抗有望用于HER2阴性、伴活动性脑转移的转移性乳腺癌患者，值得在随机临床试验中进一步验证。点击文末“阅读原文/Read more”，即可访问期刊官网阅读完整论文。推荐阅读化疗止吐重要进展！《柳叶刀-肿瘤学》：两个小改变，近60%患者完全缓解 NEJM：死亡风险降低1/3，客观缓解率翻倍，乳腺癌治疗新希望！乳腺癌无进展生存期延长近7个月！“疾病未进展先换药”策略或改写临床实践三联方案一线治疗“最毒乳腺癌”！超80%存活至少1年，PD-L1表达阴性患者也获益无需化疗，76%患者肿瘤缩小！《柳叶刀》子刊：三联疗法为转移性乳腺癌患者带来治疗新选择欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。封面图来源：123RF 参考资料 [1] Yan M, Lv H, Liu X, et al. Utidelone Plus Bevacizumab for ERBB2-Negative Metastatic Breast Cancer and Active Brain Metastases: The U-BOMB Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. Published online June 26, 2025. doi:10.1001/jamaoncol.2025.1694 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。如有其他合作需求，请联系wuxi_media@wuxiapptec.com 分享，点赞，在看，传递医学新知

放射疗法临床结果临床2期

2025-09-03

·医药观澜

破局之路：从50%死亡率，到生存率接近翻倍，卵巢癌治疗如何实现历史性跨越

编者按：卵巢癌是死亡率最高的妇科癌症之一。从手术到放化疗，再到创新靶向疗法，医学的进步持续为广泛的卵巢癌患者带来新的治疗选择。然而，临床挑战仍在：晚期卵巢癌患者的五年生存率仍未突破50%的大关。目前，全球有数百新药管线项目处于临床研究阶段，不断探索卵巢癌治疗的更多可能性。作为医药创新的赋能者，药明康德凭借一体化、端到端的CRDMO平台，持续助力全球合作伙伴加速包括卵巢癌在内的各类癌症创新药物的研发进程，致力于将更多突破性治疗方案带给癌症患者，为战胜癌症贡献力量。在全球女性癌症谱系中，卵巢癌一直以“难治”著称。难治的原因之一是其早期症状十分隐匿，约70%的患者在确诊时已处于晚期。再加上复发率高、预后较差等因素，卵巢癌也成为了主要的“妇女杀手”之一。卵巢癌的治疗策略经历了漫长的演变。从19世纪早期的开创性手术起步，当时卵巢切除术因缺乏有效的技术支持而风险极高；但在十九世纪后期，随着无菌技术和麻醉的应用，该手术的死亡率从惊人的50%大幅降至11%，成为治疗史上的重要转折。此后，医学的进步持续推动治疗策略的演进：20世纪中期引入放射治疗，70-80年代铂类与紫杉烷类化疗药物问世，直再到21世纪靶向治疗创新，每一步都为卵巢癌的治疗带来了深刻改变。近十余年来，随着靶向治疗时代的开启和新型分子疗法的不断涌现，卵巢癌的治疗格局迎来了新的转机。回望整个卵巢癌治疗的发展史，各类治疗手段的迭代演进，全球各界协同创新，共同推动着卵巢癌治疗领域的每一次重大突破。图片来源：123RF 从“无差别杀伤”到“精准打击” 自从基于铂类药物的组合化疗成为标准治疗后，晚期卵巢癌患者的5年生存率提高到了约25%，但仍然不是一个令人满意的数字。约80%的患者在接受一线治疗后有望获得完全缓解，然而残酷的是，60%~80%患者会在18个月内因化疗耐药复发，即便二线治疗有效，85%患者仍会在两年内再次出现疾病进展。临床上仍然存在着巨大的未竟医疗需求。 21世纪初，靶向治疗时代拉开了帷幕，也为卵巢癌的治疗带来了突破——开始从“无差别杀伤”的传统化疗模式，转向针对肿瘤特定分子特征的“精准打击”策略。 2011年，欧洲率先批准了抗血管生成药物Avastin（bevacizumab，贝伐珠单抗）与铂-紫杉烷类化疗的联合方案，用于晚期卵巢癌的一线治疗及维持治疗。该药物通过抑制肿瘤血管生成来“饿死”癌细胞，与化疗联用可显著延长无进展生存期。三年后，美国FDA也批准了该药在铂类耐药复发性卵巢癌二线治疗中的应用。作为一类在卵巢癌领域取得突破的生物制品，贝伐珠单抗能暂时延缓疾病进展，但难以显著延长患者的总生存时间，加上该药有可能引发一些不良反应，医学界希望找到更安全有效的新疗法。 “合成致死”，针对卵巢癌的常见突变 2014年，随着首款PARP抑制剂的问世为卵巢癌治疗带来了革命性转变。这一突破可追溯至1922年，当时哥伦比亚大学Calvin Bridges博士发现了“合成致死”现象——既两个基因同时发生突变时会导致细胞死亡，而单独突变却不会。近一个世纪后，这一机制成为了抗癌药物开发的新思路。2005年，《自然》杂志同期发表两项里程碑研究首次证实：PARP抑制剂与BRCA突变存在“合成致死”效应。其原理在于，BRCA突变会破坏癌细胞修复DNA双链断裂的能力，而PARP抑制剂则能阻断另一条修复单链断裂的通路。当两种机制同时被抑制时，癌细胞就会因无法修复DNA损伤而死亡。约15%的卵巢癌患者携带BRCA基因突变，这为PARP抑制剂的应用提供了理想靶点。经过近十年的临床探索，2014年12月，FDA批准了首款PARP抑制剂Lynparza（olaparib，奥拉帕利），用于治疗携带BRCA种系突变的晚期卵巢癌患者。奥拉帕利的成功推动了更多PARP抑制剂的研发。2016年，Zejula（niraparib，尼拉帕利）证实其对同源重组修复缺陷（HRD）阳性的非BRCA突变患者同样有效，进一步扩大了受益人群。截至目前，全球已有7款PARP抑制剂获批，其中6款可用于治疗卵巢癌，包括奥拉帕利、尼拉帕利，塞纳帕利、帕米帕利、氟唑帕利，以及和Rubraca（rucaparib）。它们通过精准打击癌细胞的DNA修复缺陷，显著延长了患者的无进展生存期。随着PARP抑制剂广泛应用于在一线维持治疗，卵巢癌患者的生存率持续提升。例如，在一项临床试验中，晚期高风险患者的5年生存率已超过40%。这一进步源于多方面的协同进展：更彻底的手术肿瘤减灭，更有效的化疗方案，PARP抑制剂的维持治疗的精准应用，以及其他靶向药物的合理组合，共同延缓了疾病复发的进程。从靶向药到免疫疗法在PARP抑制剂取得显著临床成果的同时，多种机制各异的卵巢癌创新疗法也陆续问世，为患者提供了更加丰富的治疗选择。以叶酸受体α（FRα）为例，尽管该靶点在35-40%的卵巢癌中存在高表达，但长期以来缺乏有效靶向药物。2022年11月，FDA加速批准了首个靶向FRα的抗体偶联药物（ADC）Elahere（mirvetuximab soravtansine）。该药物通过将FRα单抗与细胞毒性分子DM4偶联，实现了对铂类耐药卵巢癌的杀伤打击。值得一提的是，该疗法是首个在铂类耐药卵巢癌患者上显示带来总生存期（OS）获益的疗法：在其关键3期临床中，Elahere组患者的中位OS为16.46个月，较研究者选择（IC）化疗组的12.75个月延长近4个月。针对化疗应答率较低的卵巢癌亚型，2025年5月，FDA加速批准了RAF/MEK抑制剂avutometinib联合FAK抑制剂defactinib方案（Avmapki Fakzynja Co-Pack）用于KRAS突变型复发性低级别浆液性卵巢癌（LGSOC）。Avutometinib可同时抑制RAF和MEK，克服了传统MEK抑制剂的代偿性激活问题。在抗血管生成治疗方面，新一代重组人源化抗血管内皮生长因子（VEGF）抗体苏维西塔单抗于今年7月获中国NMPA批准，可与紫杉醇、多柔比星脂质体或拓扑替康联用治疗铂耐药后接受过不超过1种系统治疗的成人复发性卵巢癌、输卵管癌或原发性腹膜癌的治疗。在一项3期临床试验中，与对照组相比，苏维西塔单抗组显示出总生存期获益趋势（16.07个月 vs 14.88个月）。此外，该药物的临床应用不受前线VEGF通路治疗和PARP抑制剂靶向治疗的限制，与化疗联用也不受化疗种类限制。除上述靶点外，约1-2%的卵巢癌患者携带NTRK基因融合突变，该突变会驱动异常细胞生长和癌症进展。Vitrakvi（larotrectinib，拉罗替尼）和Rozlytrek（entrectinib，恩曲替尼）能够阻断突变NTRK基因产生异常蛋白质，适用于那些经治后进展、携带NTRK基因突变的晚期卵巢癌患者。在靶向疗法不断突破的同时，免疫治疗也为卵巢癌患者带来新的希望。癌细胞常利用免疫“检查点”机制逃避免疫监视，以PD-1/PD-L1抑制剂为代表的免疫检查点抑制剂，通过阻断这一逃逸通路，能够重新激活T细胞对癌细胞的杀伤作用。目前，包括Keytruda（pembrolizumab，帕博利珠单抗）、Jemperli（dostarlimab）和百泽安（替雷利珠单抗）在内的多种PD-1抑制剂已获得监管批准，用于治疗不可切除或转移性微卫星高度不稳定型（MSI-H）或错配修复基因缺陷型（dMMR）的晚期实体瘤患者，其中也包括卵巢癌患者。靶向治疗与免疫疗法的持续涌现，正推动卵巢癌治疗迈向精准化和个体化的新时代。随着对卵巢癌分子机制理解的深入以及创新药物的不断研发，临床医生得以依据患者的分子特征，选择更加匹配的治疗策略，为不同亚型的卵巢癌患者提供更具针对性的治疗选择。一体化平台赋能卵巢癌新药开发从十九世纪的卵巢切除术发展至如今的精准靶向治疗，人类对抗卵巢癌的征程已走过一条漫长而艰辛的道路。一方面看，治疗手段不断革新，给患者带来了新的希望。然而另一方面，晚期卵巢癌患者的五年生存率至今仍未突破50%。这一现实始终提醒我们：与卵巢癌这一“沉默杀手”的较量，依然任重而道远。根据公开资料，目前有数百卵巢癌疗法研发管线已进入临床开发阶段。长期以来，药明康德都在支持全球合作伙伴从药物研究（R）、开发（D）到商业化生产（M）各个阶段的需求，通过独特的一体化、端到端CRDMO模式，助力突破性疗法加速研发进程、早日惠及患者。我们很高兴能赋能来自全球客户的卵巢癌新药的开发，也将继续与全球合作伙伴携手同行，共同推动卵巢癌治疗的突破，让更多患者迎来曙光！免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。

放射疗法

2025-09-02

·GlobeNewswire-Health Care

Outlook Therapeutics Requests Type A Meeting with FDA

ISELIN, N.J., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced that a Type A Meeting request has been submitted to the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. In the FDA’s recently issued CRL, although the Agency acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, it recommended that confirmatory evidence of efficacy be submitted to support the application for ONS-5010. The requested Type A meeting seeks to clarify the details of the confirmatory evidence required by the FDA. “We believe this Type A meeting will provide us with additional clarity on the FDA’s requirements to remedy the deficiency identified in the CRL,” commented Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “The Outlook Therapeutics team remains dedicated to our mission to provide patients in the U.S. with a safe and effective alternative to compounded bevacizumab, which has been used off-label as a first-line treatment for wet-AMD for years despite concerns around potency, sterility, consistency and regulatory oversight associated with the use of compounded products.” About ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. In certain European Union Member States ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold. Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina. About Outlook Therapeutics, Inc. Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) to optimize the standard of care for bevacizumab for the treatment of retina diseases. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD. In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “expect,” “intend,” “may,” “on track,” “plan,” “potential,” “seek,” “target,” “will,” or “would” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, plans to meet with the FDA, seek additional clarity on the FDA’s requirements to and work to address the deficiency identified in the CRL, the potential to obtain FDA approval for ONS-5010, the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD and to mitigate certain risks associated with the current off-label use of repackaged bevacizumab, and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, including the risk that the Outlook Therapeutics is unable to address the issues identified in the CRL and ultimately obtain FDA approval, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, as supplemented by the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2025 and future reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, tariffs and trade tensions, fluctuations in interest rates and inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law. Investor Inquiries:Jenene ThomasChief Executive OfficerJTC Team, LLCT: 908.824.0775OTLK@jtcir.com

上市批准

100 项与贝伐珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06409	贝伐珠单抗	L01XC07	DB00112

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
不可切除的肝细胞癌	日本	Chugai Pharmaceutical Co., Ltd.	2020-09-25
肝细胞癌	美国	Genentech, Inc.	2020-05-29
复发性胶质母细胞瘤	美国	Genentech, Inc.	2020-05-29
复发性原发性腹膜癌	美国	Genentech, Inc.	2014-11-14
卵巢癌	日本	Chugai Pharmaceutical Co., Ltd.	2013-11-22
胶质瘤	日本	Chugai Pharmaceutical Co., Ltd.	2013-06-14
乳腺癌	日本	Chugai Pharmaceutical Co., Ltd.	2011-09-26
结直肠癌	日本	Chugai Pharmaceutical Co., Ltd.	2009-09-18
转移性肾细胞癌	美国	Genentech, Inc.	2009-07-31
胶质母细胞瘤	美国	Genentech, Inc.	2009-05-05
转移性结直肠癌	美国	Genentech, Inc.	2009-05-05
节细胞神经胶质瘤	日本	Chugai Pharmaceutical Co., Ltd.	2007-04-18
非鳞状非小细胞肺癌	美国	Genentech, Inc.	2006-10-11
输卵管癌	欧盟	Roche Registration GmbH	2005-01-12
输卵管癌	冰岛	Roche Registration GmbH	2005-01-12
输卵管癌	列支敦士登	Roche Registration GmbH	2005-01-12
输卵管癌	挪威	Roche Registration GmbH	2005-01-12
转移性乳腺癌	欧盟	Roche Registration GmbH	2005-01-12
转移性乳腺癌	冰岛	Roche Registration GmbH	2005-01-12
转移性乳腺癌	列支敦士登	Roche Registration GmbH	2005-01-12

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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
晚期头颈癌	临床3期	美国	National Cancer Institute	2023-03-13
头颈部皮肤鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-03-13
头颈癌转移	临床3期	美国	National Cancer Institute	2023-03-13
鼻咽癌	临床3期	美国	National Cancer Institute	2023-03-13
鼻咽鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-03-13
口咽肿瘤	临床3期	美国	National Cancer Institute	2023-03-13
复发性咽部鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-03-13
复发性头颈部鳞状细胞癌	临床3期	美国	National Cancer Institute	2023-03-13
早产儿视网膜病变	临床3期	美国	Jaeb Center For Health Research Foundation, Inc.	2022-04-27
早产儿视网膜病变	临床3期	加拿大	Jaeb Center For Health Research Foundation, Inc.	2022-04-27

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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


NCT04958811 (WCLC2025)	临床2期	鳞状细胞肺癌二线 PDL1 TPS ≥1%	12	bevacizumab+Atezolizumab+Tiragolumab	膚鑰鹹廠醖夢遞齋鹽遞(鏇餘築範願廠憲鹹獵觸) = 夢窪鹽遞願夢繭顧齋鏇淵獵膚遞襯壓繭齋願淵 (窪廠衊壓繭襯襯遞簾餘 ) 更多	积极	2025-09-07
NCT02681549 (Phase II Trial of Pembrolizumab in Combination With Bevacizumab for Untreated Melanoma Brain Metastases, CTgov)	临床2期	非小细胞肺癌 \| 转移性黑色素瘤 \| 鳞状非小细胞肺癌 ... 更多	41	Pembrolizumab+Bevacizumab (Untreated Brain Metastases From Melanoma)	遞簾餘廠顧選淵淵鏇齋 = 範築糧齋鏇範壓餘壓繭醖鏇顧淵壓齋鑰顧鏇艱 (淵齋簾願蓋齋觸鹹蓋憲, 獵廠蓋鏇衊鹹構鑰鑰顧 ~ 糧窪鏇衊膚膚鏇範簾簾) 更多	-	2025-08-07
				Pembrolizumab+Bevacizumab (Untreated Brain Metastases From NSCLC)	遞簾餘廠顧選淵淵鏇齋 = 鏇醖窪夢艱選獵鹽構鹹醖鏇顧淵壓齋鑰顧鏇艱 (淵齋簾願蓋齋觸鹹蓋憲, 選簾窪醖顧憲醖鑰壓範 ~ 襯夢襯簾範憲積膚製餘) 更多
NCT05357417 (U-BOMB, Pubmed \| JAMA Oncol) 人工标引	临床2期	转移性HER2阴性乳腺癌 HER2/Neu Negative	47	Utidelone +Bevacizumab	襯積積窪衊齋夢鑰構糧(選廠膚選蓋糧窪製窪鹽) = 網窪鹽襯蓋廠艱積鹽積淵網築範鏇糧範窪壓鏇 (淵齋淵繭淵範糧鹽醖餘, 28.3 ~ 57.8) 更多	积极	2025-08-01
DUBHE-L-201 (Pubmed \| J Hematol Oncol) 人工标引	临床2期	EGFR突变的非小细胞肺癌 EGFR Mutation	31	Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (cohort 5)	餘廠獵鹹鹹襯選鬱淵願(鏇繭顧襯製糧淵製網觸) = 壓願膚淵選醖顧鬱鬱製顧膚繭願獵製鏇願糧蓋 (蓋獵膚鬱簾積網糧餘繭, 12.81 ~ NR) 更多	积极	2025-07-26
				Iparomlimab and tuvonralimab (QL1706) + Bevacizumab + Chemotherapy (21L858R mutation + cohort 5)	餘廠獵鹹鹹襯選鬱淵願(鏇繭顧襯製糧淵製網觸) = 鏇遞願壓憲蓋築襯齋繭顧膚繭願獵製鏇願糧蓋 (蓋獵膚鬱簾積網糧餘繭 ) 更多
NCT03574779 (OPAL Phase II Trial \| OPAL, CTgov)	临床2期	卵巢癌	77	Niraparib+Bevacizumab+Dostarlimab (Cohort A (Dostarlimab + Bevacizumab + Niraparib))	襯網壓網築範構製鹹憲 = 夢積鹹壓夢窪遞壓膚夢膚醖顧遞醖獵構顧鏇艱 (鏇壓衊衊選網艱膚築製, 觸鑰襯範蓋鑰鹹網遞壓 ~ 製簾廠鹽範獵築廠衊網) 更多	-	2025-07-15
				taxane+Niraparib (Cohort C (Niraparib OR Platinum-taxane))	襯網壓網築範構製鹹憲 = 壓簾鬱積鹹網艱襯窪獵膚醖顧遞醖獵構顧鏇艱 (鏇壓衊衊選網艱膚築製, 鹹廠膚淵壓廠膚製築願 ~ 築醖製壓觸製繭憲選選) 更多
NCT04712643 (TALENTACE, NEWS \| ASCO_GI2025) 人工标引	临床3期	不能切除的恶性肝癌	342	TACE+阿替利珠单抗+贝伐珠单抗	醖餘繭糧鏇艱範齋觸製(鑰積鑰顧鬱鹹獵顧獵鏇) = 鑰醖簾廠齋齋蓋鹹觸願餘築憲艱衊築壓顧夢簾 (繭顧網蓋夢壓鹹遞製製 ) 更多	积极	2025-07-04
				单独TACE	醖餘繭糧鏇艱範齋觸製(鑰積鑰顧鬱鹹獵顧獵鏇) = 鑰鬱醖鹹製壓糧鏇淵顧餘築憲艱衊築壓顧夢簾 (繭顧網蓋夢壓鹹遞製製 ) 更多
NCT04487067 (AMETHISTA, ESMO_GI2025) 人工标引	临床3期	不可切除的肝细胞癌一线	149	Atezolizumab plus bevacizumab	範膚艱醖築淵觸廠選糧(壓構蓋築窪鬱選觸襯選) = 構壓網淵膚醖鬱衊齋衊簾夢築願餘壓遞淵鏇繭 (鹹糧淵鬱製膚鹹積築構 ) 更多	积极	2025-07-03
NCT04607421 (BREAKWATER, ESMO_GI2025) 人工标引	临床3期	BRAF V600E突变结直肠癌一线 BRAF V600E	243	FOLFOXIRI+bevacizumab (bev)	鏇齋遞積艱繭鏇憲夢鬱(齋鏇遞襯顧選製鑰襯壓) = 艱襯網網壓鹹醖壓築積願鏇範壓鑰醖糧鬱淵積 (鹹範襯繭醖遞鹹鹹壓餘, 43.3 ~ 67.8) 更多	积极	2025-07-03
				mFOLFOX6+bevacizumab (bev)	鏇齋遞積艱繭鏇憲夢鬱(齋鏇遞襯顧選製鑰襯壓) = 餘觸願遞鑰衊壓窪構襯願鏇範壓鑰醖糧鬱淵積 (鹹範襯繭醖遞鹹鹹壓餘, 29.1 ~ 48.1) 更多
NCT04732286 (ATHECA, ESMO_GI2025) 人工标引	临床3期	不可切除的肝细胞癌一线	100	Atezolizumab + Bevacizumab	構廠窪壓齋選積壓顧夢(艱鹽顧製衊齋鹽鹹壓餘) = 積廠鏇願繭夢積鏇積願壓餘壓選願製鹽艱鹹範 (製網顧積壓範襯遞衊願 ) 更多	积极	2025-07-03
NCT05247619 (Pubmed \| EClinicalMedicine) 人工标引	临床2期	复发性宫颈癌 \| 宫颈癌 \| 转移性宫颈癌一线	51	tislelizumab + bevacizumab +paclitaxel+cisplatin/tislelizumab + bevacizumab +paclitaxel+carboplatin	範構淵齋選醖願顧夢網(餘襯鹽鑰艱糧築製獵製) = 鏇衊鏇廠鏇廠範鏇糧淵築蓋築憲鑰窪鏇壓膚醖 (選簾積願鬱糧選繭鏇壓, 14.6 ~ NR) 更多	积极	2025-06-24