阿斯利康，Daiichi Sankyo ADC在晚期癌症获得FDA批准-动脉网

AstraZeneca, Daiichi Sankyo ADC Lands FDA Approval in Advanced Breast Cancer

MedCity News 等信源发布 2025-01-21 00:09

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可切换为仅中文

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A targeted cancer therapy from AstraZeneca’s alliance with Daiichi Sankyo is now

阿斯利康（AstraZeneca）与第一三共（Daiichi Sankyo）的联盟目前正在进行针对性的癌症治疗

FDA approved

FDA批准

to treat certain cases of advanced breast cancer, giving the British pharmaceutical giant another product to fill out an oncology portfolio that’s a key part of its revenue growth strategy.

治疗某些晚期乳腺癌病例，为这家英国制药巨头提供另一种产品，以填补其收入增长战略的关键部分——肿瘤学投资组合。

The regulatory decision announced late Friday covers the treatment of adults with advanced cases of breast cancer that is HR positive and HER2 negative and cannot be removed by surgery. Also, these cancers must have advanced or spread following treatment with an endocrine-based therapy and chemotherapy.

周五晚些时候宣布的监管决定涵盖了HR阳性和HER2阴性且无法通过手术切除的晚期乳腺癌患者的治疗。此外，这些癌症必须在内分泌治疗和化疗后进展或扩散。

The drug, known in development as datopotamab deruxtecan, or Dato-DXd, will be marketed under the brand name Datroway..

这种药物在开发中被称为达托巴单抗（datopotamab deruxtecan）或达托DXd，将以Datroway品牌销售。。

Datroway is part of a class of therapies called antibody drug conjugates (ADCs), which are made by linking a toxic chemotherapy payload to a targeting antibody. The target of Datroway is TROP2, a protein abundant on the surface of many types of cancer cells, including breast cancer cells.

Datroway是一类称为抗体-药物偶联物（ADC）的疗法的一部分，该疗法是通过将毒性化疗有效载荷与靶向抗体连接而制成的。Datroway的靶标是TROP2，TROP2是一种富含多种癌细胞表面的蛋白质，包括乳腺癌细胞。

presented by

提交人

Health IT

健康IT

Transforming Patient Care: The Role of AI-Powered Assistants

The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes.

人工智能（AI）的进步正在从各个方面重塑患者护理，从促进更快的出院到策划治疗计划并建议改变生活方式。

By IT Medical

通过IT Medical

The AstraZeneca/Daiichi Sankyo drug was evaluated in an open-label Phase 3 study that enrolled 732 patients with advanced breast cancer. Study participants were randomly assigned to receive the study drug or chemotherapy. The main goals were measuring progression-free survival and overall survival. Results showed median progression-free survival of 6.9 months in the Datroway arm compared with 4.9 months in the chemotherapy arm, which was enough to be statistically significant.

阿斯利康/第一三共药物在一项开放标签的3期研究中进行了评估，该研究招募了732名晚期乳腺癌患者。研究参与者被随机分配接受研究药物或化疗。主要目标是测量无进展生存期和总生存期。结果显示，Datroway组的中位无进展生存期为6.9个月，而化疗组为4.9个月，这足以具有统计学意义。

But Datroway fell short of statistical significance on the measure of overall survival, with a median 18.6 months in the study drug arm compared with 18.3 months for those treated with chemo..

但Datroway在总体生存率方面没有统计学意义，研究药物组的中位生存期为18.6个月，而化疗组的中位生存期为18.3个月。。

AstraZeneca already markets an ADC for breast cancer. Enhertu was initially approved in 2019 as a treatment for HER2-positive breast cancer. The ADC’s approval later expanded to include

阿斯利康已经推出了一种乳腺癌ADC。Enhertu最初于2019年被批准用于治疗HER2阳性乳腺癌。ADC的批准后来扩大到包括

HER2-low metastatic breast cancer

HER2低转移性乳腺癌

and

和

HER2-positive non-small cell lung cancer

HER2阳性非小细胞肺癌

. Last year, the FDA approved Enhertu for treating

去年，FDA批准Enhertu用于治疗

solid tumors regardless of where they’re found in the body

实体瘤无论在体内何处发现

as long as they express HER2. AstraZeneca has set a goal bringing to market at least 20 new drugs by 2030, growing annual revenue to $80 billion. The company said Datroway is now the eighth new medicine for its 2030 goal.

只要他们表达HER2。阿斯利康（AstraZeneca）制定了一个目标，到2030年将至少20种新药推向市场，使年收入增长至800亿美元。该公司表示，达特罗韦目前是其2030年目标的第八种新药。

“With this first approval of Datroway in the U.S., we continue to deliver on our ambition for antibody drug conjugates to improve upon and replace conventional chemotherapy for the treatment of multiple cancers,” Dave Fredrickson, executive vice president, oncology hematology business unit, AstraZeneca, said in a prepared statement..

阿斯利康肿瘤血液业务部执行副总裁戴夫·弗雷德里克森在一份准备好的声明中说：“随着达特罗韦在美国的首次批准，我们继续实现抗体-药物偶联物的雄心壮志，以改进和替代常规化疗来治疗多种癌症。”。。

Biopharma information services firm Citeline included Datroway in its

生物制药信息服务公司Citeline将Datroway纳入其

report

报告

on key potential drug launches for 2025. The drug’s Phase 3 results are comparable to those of

2025年可能推出的关键药物。该药物的3期结果与

Trodelvy, a TROP2-targeting ADC marketed by Gilead Sciences

Trodelvy，一种由Gilead Sciences销售的针对TROP2的ADC

as a second-line treatment for HR positive, HER2 negative breast cancer, the report said. But Datroway’s results come up short compared with Enhertu.

报告称，作为HR阳性、HER2阴性乳腺癌的二线治疗。但与Enhertu相比，Datroway的结果并不理想。

Healthcare

医疗保健

Using Data to Help Healthcare Practices Succeed

利用数据帮助医疗实践取得成功

A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices.

Relatient的一份新报告（一份数据驱动的患者访问成功指南）强调了关注数据准确性和相关性如何提高医疗保健实践的绩效。

By Relatient

按亲属

The Citeline report also noted one treatment-related death in the Datroway trial. Given that patients with advanced breast cancer have other treatment options, the potential safety risks could place the drug lower on a physicians’ lists of available therapies, Citeline said. For those reasons, Datroway is unlikely to stand out as a leader in this setting and is expected to get a small piece of market share, the report said..

Citeline报告还指出Datroway试验中有一例与治疗相关的死亡。Citeline说，鉴于晚期乳腺癌患者有其他治疗选择，潜在的安全风险可能会使该药物在医生的可用治疗列表中排名较低。报告称，由于这些原因，Datroway不太可能在这方面脱颖而出，并有望获得一小部分市场份额。。

AstraZeneca said Datroway submissions in breast cancer are still under regulatory review in Europe and China, among other markets. The company is also seeking to expand use of the drug to other cancers. Last week, the

阿斯利康表示，Datroway提交的乳腺癌报告仍在欧洲和中国以及其他市场接受监管审查。该公司还寻求将该药物的使用扩展到其他癌症。上周

FDA accepted

FDA接受

an application seeking approval of the ADC for EGFR-mutated non-small cell lung cancer. A regulatory decision in this indication is expected in the third quarter of this year.

寻求ADC批准EGFR突变的非小细胞肺癌的申请。。

Public domain

公共领域

image

形象

by the National Cancer Institute

国家癌症研究所

Topics

主题

antibody drug conjugate

抗体-药物偶联物

AstraZeneca