–

–

BLA

黑色

based on data from the global Phase 1/2 CADENZA trial

基于全球 1/2 期 CADENZA 试验的数据

NORTH CHICAGO, Ill.

伊利诺伊州北芝加哥市

,

，

Sept. 30, 2025

2025年9月30日

/

/

PRNewswire

美通社

/ -- AbbVie (NYSE: ABBV) today announced submission of a new Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of investigational Pivekimab sunirine (PVEK) for treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). The submission is based on data from the Phase 1/2 CADENZA trial, a global study evaluating the safety and efficacy of PVEK in BPDCN. BPDCN is a rare and aggressive blood cancer that has features of both leukemia and lymphoma.

/ -- 艾伯维（AbbVie，纽约证券交易所代码：ABBV）今天宣布向美国食品药品监督管理局（FDA）提交了一份新的生物制品许可申请（BLA），以寻求批准在研药物Pivekimab sunirine（PVEK）用于治疗母细胞性浆细胞样树突细胞肿瘤（BPDCN）。该申请基于1/2期CADENZA试验的数据，这是一项全球性研究，评估了PVEK在BPDCN中的安全性和有效性。BPDCN是一种罕见且侵袭性的血液癌症，兼具白血病和淋巴瘤的特征。

Patients typically present with skin lesions and the disease often spreads to the bone marrow, central nervous system and the lymph nodes. First-line treatments are typically intensive chemotherapy and often followed by stem cell transplant. The need for additional and innovative treatment is high for both newly diagnosed patients and for those whose prior treatments have resulted in relapsed or refractory disease..

患者通常出现皮肤病变，疾病常扩散至骨髓、中枢神经系统和淋巴结。一线治疗通常为强化化疗，随后常进行干细胞移植。无论是新诊断的患者还是先前治疗导致复发或难治性疾病的患者，对额外和创新治疗的需求都很高。

PVEK is a CD123-targeting Antibody-Drug Conjugate (ADC) in clinical development for hematological malignancies (blood cancers), including BPDCN and acute myeloid leukemia (AML). ADCs are designed to deliver potent cancer cell death-inducing agents called 'payloads' directly to the cancer cells expressing a specific protein.

PVEK是一种针对CD123的抗体药物偶联物（ADC），目前正处于血液系统恶性肿瘤（血癌）的临床开发阶段，包括BPDCN和急性髓系白血病（AML）。ADC旨在将强效诱导癌细胞死亡的药剂（称为“有效载荷”）直接递送至表达特定蛋白质的癌细胞。

CD123 (IL-3Rα) is a protein overexpressed in BPDCN, making it an ideal target for therapy..

CD123（IL-3Rα）是在BPDCN中过度表达的蛋白质，因此它成为治疗的理想靶点。

'Meaningful innovations in cancer research and treatment are happening every day. It is important that these innovations reach patients who desperately need them, including those with rare cancers who have limited options,' said

“癌症研究和治疗领域每天都有重要的创新出现。重要的是，这些创新能够惠及迫切需要它们的患者，包括那些选择有限的罕见癌症患者，”

Roopal Thakkar

鲁帕尔·塔卡尔

, executive vice president, research and development and chief scientific officer, AbbVie. 'We look forward to next steps in the regulatory process for our latest Antibody-Drug Conjugate (ADC), our first ADC in blood cancer, and how it may advance treatment for those living with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN).'.

“ AbbVie执行副总裁，研发部门及首席科学官。‘我们期待在我们最新的抗体药物偶联物（ADC）——我们在血癌领域的首个ADC——的监管进程中的下一步，并且它可能为患有母细胞性浆细胞样树突细胞肿瘤（BPDCN）的患者带来治疗上的进步。’”

About the

关于

CADENZA Trial

华彩试验

CADENZA is a Phase 1/2 multicenter, open-label study designed to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing schedule for PVEK monotherapy and to assess the safety, tolerability, PK, immunogenicity, and antileukemia activity of PVEK when administered to subjects with CD123+ hematologic malignancies (including subjects with BPDCN, AML, and others)..

CADENZA 是一项 Phase 1/2 多中心、开放标签研究，旨在确定 PVEK 单药治疗的最大耐受剂量 (MTD)、推荐的 Phase 2 剂量 (RP2D) 和推荐的给药方案，并评估 PVEK 在 CD123+ 血液系统恶性肿瘤（包括 BPDCN、AML 等）患者中的安全性、耐受性、药代动力学 (PK)、免疫原性和抗白血病活性。

About Pivekimab Sunirine (PVEK)

关于Pivekimab Sunirine（PVEK）

PVEK is a CD123-targeting ADC in clinical development for hematological malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN) and acute myeloid leukemia (AML). PVEK is currently being evaluated as monotherapy for patients with BPDCN and in combination with Vidaza

PVEK是一种针对CD123的抗体药物偶联物（ADC），目前正用于血液系统恶性肿瘤的临床开发，包括母细胞性浆细胞样树突细胞肿瘤（BPDCN）和急性髓系白血病（AML）。PVEK目前正作为单药治疗BPDCN患者进行评估，并与Vidaza联合使用进行研究。

®

®

(azacitidine) and Venclexta

（阿扎胞苷）和维奈克拉

®

®

(venetoclax) for patients with untreated and relapsed/refractory AML. In October 2020, the FDA granted PVEK Breakthrough Therapy designation in relapsed/refractory BPDCN.

（维奈托克）用于未经治疗和复发/难治性AML患者。2020年10月，FDA授予PVEK突破性疗法认定，用于复发/难治性BPDCN。

About AbbVie in Oncology

关于艾伯维在肿瘤学领域

AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination.

AbbVie 致力于提升护理标准，并为全球患有难治癌症的患者带来变革性疗法。我们正在推进一系列癌症类型的血液癌和实体瘤研究疗法的动态管线。我们专注于开发靶向药物，以阻碍癌细胞的繁殖或实现其清除。

We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibody and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines..

我们通过各种有针对性的治疗方式和生物干预措施来实现这一目标，包括小分子治疗药物、抗体药物偶联物 (ADC)、基于免疫肿瘤学的治疗药物、多特异性抗体以及新型 CAR-T 平台。我们专注且经验丰富的团队与创新合作伙伴携手，加速潜在突破性药物的交付。

Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines.

如今，我们广泛的肿瘤学产品组合包括已获批和正在研究的针对多种血液癌症和实体瘤的治疗方法。我们正在对35种以上的研究药物进行多项临床试验，涵盖一些全球最普遍和致残的癌症。在努力对人们的生活产生显著影响的同时，我们致力于探索解决方案，帮助患者获得我们的抗癌药物。

For more information, please visit .

如需更多信息，请访问 。

http://www.abbvie.com/oncology

http://www.abbvie.com/oncology

.

。

About AbbVie

关于艾伯维

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio.

艾伯维的使命是发现并提供创新的药物和解决方案，以解决当今严重的健康问题，并应对未来的医疗挑战。我们力求在包括免疫学、肿瘤学、神经科学和眼科护理在内的几个关键治疗领域，以及我们艾尔建美学产品组合中的产品和服务，对人们的生活产生显著影响。

For more information about AbbVie, please visit us at .

有关艾伯维的更多信息，请访问我们的网站。

www.abbvie.com

www.abbvie.com

. Follow @abbvie on

关注 @abbvie

LinkedIn,

领英，

Facebook

脸书

,

，

Instagram

图享

,

，

X (formerly Twitter)

X（前称Twitter）

and

和

YouTube.

YouTube。

Forward-Looking Statements

前瞻性声明

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words 'believe,' 'expect,' 'anticipate,' 'project' and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements.

本新闻稿中的某些陈述，或者可能被视为前瞻性陈述，依据的是1995年《私人证券诉讼改革法案》。诸如“相信”、“预期”、“预见”、“计划”等词语及类似表达和未来或条件动词的使用，通常用于识别前瞻性陈述。

AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations.

AbbVie提醒，这些前瞻性陈述受到可能导致实际结果与前瞻性陈述中明示或暗示的结果存在重大差异的风险和不确定性的影响。这些风险和不确定性包括但不限于：知识产权面临的挑战、来自其他产品的竞争、研发过程中固有的困难、不利的诉讼或政府行为、适用于我们行业的法律法规的变化、全球宏观经济因素的影响，如经济衰退或不确定性、国际冲突、贸易争端和关税，以及与全球业务运营相关的其他不确定性和风险。

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, 'Risk Factors,' of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information.

有关可能影响艾伯维公司运营的经济、竞争、政府、技术及其他因素的更多信息，请参阅艾伯维公司2024年Form 10-K年度报告中的第1A项“风险因素”，该报告已提交给美国证券交易委员会，并通过其后提交的季度报告Form 10-Q以及其他更新、补充或取代该信息的文件进行了更新。

AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. .

AbbVie 不承担任何义务，并明确拒绝因后续事件或发展而公开发布对前瞻性声明的任何修订，除非法律要求。

U.S. Media:

美国媒体：

Ilke Limoncu

伊尔克·利蒙丘

Ilke.limoncu@abbvie.com

伊尔克·利蒙楚@abbvie.com

Investors:

投资者：

Liz Shea

利兹·谢伊

liz.shea@abbvie.com

liz.shea@abbvie.com

SOURCE AbbVie

来源：艾伯维（AbbVie）