AstraZeneca and Daiichi Sankyo have claimed approval from the European Commission for their TROP2-directed antibody-drug conjugate (ADC) for breast cancer, Datroway, the latest to emerge from their multibillion-dollar alliance.

阿斯利康和第一三共宣布，其针对TROP2的抗体药物偶联物（ADC）Datroway已获欧盟委员会批准用于乳腺癌治疗，这是他们数十亿美元合作联盟中最新成果。

Datroway

达特罗威

(datopotamab deruxtecan) has been given the green light in the EU as a treatment for patients with metastatic HR-positive, HER2-negative breast cancer who have previously been treated with endocrine therapy and at least one line of chemotherapy.

（datopotamab deruxtecan）已在欧盟获得批准，用于治疗先前接受过内分泌治疗和至少一种化疗的转移性激素受体阳性、HER2阴性乳腺癌患者。

It is the second ADC brought to market by AZ and Daiichi Sankyo after

这是阿斯利康和第一三共在市场推出的第二款ADC药物，继

Enhertu

恩赫图

(trastuzumab deruxtecan), a HER2-targeting ADC that is already a blockbuster with sales of more than $3.75 billion in 2024, up from $2.57 billion in the prior year. EU approval takes the tally of countries that have approved Datroway to more than 30, also including the US and Japan.

（trastuzumab deruxtecan），一种已经大获成功的HER2靶向ADC药物，2024年的销售额超过37.5亿美元，高于前一年的25.7亿美元。欧盟的批准使Datroway获得批准的国家数量增加到30多个，其中包括美国和日本。

It is also the second TROP2-targeting ADC to reach the EU market after Gilead Sciences'

这也是继吉利德科学（Gilead Sciences）之后，第二个进入欧盟市场的靶向TROP2的ADC。

Trodelvy

特罗德尔维

(sacituzumab govitecan), which was approved for a similar HR-positive, HER2-negative breast cancer population in 2023 and can also be used to treat triple-negative breast cancer (TNBC).

（sacituzumab govitecan），该药物于2023年被批准用于类似的激素受体阳性、HER2阴性的乳腺癌人群，也可用于治疗三阴性乳腺癌（TNBC）。

There's another potential competitor on the way as well, as MSD is running late-stage trials of its

此外，还有一个潜在的竞争对手在路上，因为MSD正在运行其后期试验

sacituzumab tirumotecan

戈沙妥珠单抗 tirumotecan

candidate – licensed from Kelun – in several indications spanning breast, lung, and other solid tumours. The drug has already been

候选药物——来自科伦药业授权——涵盖乳腺癌、肺癌及其他实体瘤等多个适应症。该药物已经被

approved

已批准

in China for lung cancer.

在中国，针对肺癌。

The EU approval of Datroway is based on the results of the TROPION-Breast01 study, which revealed that patients treated with the ADC had a median progression-free survival (PFS) of 6.9 months compared to 4.9 months for those receiving chemotherapy, a 37% improvement.

欧盟对Datroway的批准是基于TROPION-Breast01研究的结果，该研究表明，接受ADC治疗的患者中位无进展生存期（PFS）为6.9个月，而接受化疗的患者为4.9个月，提高了37%。

'With the majority of breast cancer cases historically considered HR-positive, HER2-negative, additional treatment options are needed to improve outcomes for patients with metastatic disease that continues to progress following endocrine-based therapy and initial chemotherapy,' commented Barbara Pistilli, who leads the breast cancer unit at the Gustave Roussy Cancer Centre in Villejuif, France..

“历史上大多数乳腺癌病例被认为是激素受体阳性、HER2阴性，对于那些在接受内分泌治疗和初步化疗后疾病仍在继续发展的转移性患者，我们需要更多的治疗选择来改善他们的预后，”法国维尔瑞夫古斯塔夫·鲁西癌症中心乳腺癌部门负责人巴巴拉·皮斯蒂利评论道。

'The approval of Datroway in the EU will provide these patients with a new treatment option that can help slow the progression of this disease,' she added.

“达特鲁韦在欧盟的获批将为这些患者提供一种新的治疗选择，有助于减缓这种疾病的进展，”她补充道。

At one point, AZ and Daiichi Sankyo were also hoping to get EU approval for the TROP2 drug as a treatment for locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) based on the

一度，阿斯利康和第一三共还希望基于此获得欧盟对TROP2药物用于局部晚期或转移性非鳞状非小细胞肺癌（NSCLC）治疗的批准。

TROPION-Lung01

TROPION-Lung01

study but withdrew the application in December after the EU regulator said it did not consider the evidence for that use to be sufficiently strong.

学习，但在欧盟监管机构表示认为该用途的证据不够充分后，于十二月撤回了申请。

AstraZeneca has a target of $5 billion or more in peak annual sales for both Enhertu and Datroway, making the pair a core part of its objective of achieving $80 billion in group revenues by 2030.

阿斯利康为Enhertu和Datroway设定的销售目标是每年峰值达到50亿美元或更多，这使得这两款药物成为其实现到2030年集团收入达到800亿美元目标的核心部分。

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照片由

National Cancer Institute

国家癌症研究所

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