Daiichi Sankyo and AstraZeneca have received accelerated approval from the U.S. Food and Drug Administration (FDA) for DATROWAY® (datopotamab deruxtecan-dlnk) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR mutations.

第一三共和阿斯利康已获得美国食品药品监督管理局（FDA）的加速批准，用于DATROWAY®（datopotamab deruxtecan-dlnk）治疗携带EGFR突变的局部晚期或转移性非小细胞肺癌（NSCLC）成年患者。

DATROWAY is a TROP2-directed ADC composed of a humanised anti-TROP2 monoclonal antibody linked to a topoisomerase I inhibitor payload using a cleavable linker. It is part of Daiichi Sankyo’s DXd ADC pipeline and a key component of AstraZeneca’s oncology portfolio.

DATROWAY是一种TROP2导向的抗体药物偶联物（ADC），由人源化的抗TROP2单克隆抗体通过可裂解连接子与拓扑异构酶I抑制剂载荷连接而成。它是第一三共DXd ADC管线的一部分，也是阿斯利康肿瘤学产品组合中的关键组成部分。

Non-small cell lung cancer (NSCLC) accounts for nearly 87% of all lung cancer cases globally. Among these, EGFR mutations are present in around 10–15% of U.S. and European patients, and up to 40% of those in Asia.

非小细胞肺癌（NSCLC）占全球所有肺癌病例的近87%。其中，美国和欧洲患者中约有10%-15%存在EGFR突变，而在亚洲患者中这一比例高达40%。

TROPION-Lung05 is a global, single-arm, phase 2 trial involving patients with actionable genetic alterations in NSCLC who had received prior targeted therapy and platinum-based chemotherapy. The study enrolled 137 patients worldwide and focused on ORR as the primary endpoint.

TROPION-Lung05 是一项全球性、单臂、二期临床试验，涉及携带可靶向基因变异的非小细胞肺癌患者，这些患者先前接受过靶向治疗和铂类化疗。该研究在全球范围内招募了 137 名患者，并将客观缓解率（ORR）作为主要终点。

TROPION-Lung01 is a phase 3 trial comparing DATROWAY with docetaxel in previously treated patients with and without actionable mutations. The primary endpoints are progression-free survival (PFS) and overall survival (OS). It enrolled 590 patients across five continents.

TROPION-Lung01 是一项 III 期临床试验，比较 DATROWAY 与多西他赛在既往接受过治疗的、携带或不携带可靶向突变的患者中的疗效。主要终点是无进展生存期 (PFS) 和总生存期 (OS)。该试验在全球五大洲招募了 590 名患者。

TROPION-PanTumor01 is a phase 1 trial assessing DATROWAY in patients with advanced solid tumours. The study evaluated safety and preliminary efficacy across various tumour types and enrolled 890 patients in Asia and North America.

TROPION-PanTumor01 是一项评估 DATROWAY 在晚期实体瘤患者中的 1 期试验。该研究评估了多种肿瘤类型的安全性和初步疗效，并在亚洲和北美招募了 890 名患者。

This approval applies to patients who have previously been treated with EGFR-targeted therapy and platinum-based chemotherapy. The decision is based on objective response rate (ORR) and duration of response (DoR), with continued approval potentially subject to confirmation of clinical benefit in further studies..

该批准适用于先前接受过EGFR靶向治疗和铂类化疗的患者。该决定基于客观缓解率（ORR）和缓解持续时间（DoR），继续批准可能取决于进一步研究中临床获益的确认。

The approval is based on data from the TROPION-Lung05 and TROPION-Lung01 trials. In these studies, DATROWAY showed an objective response rate (ORR) of 45% in patients with previously treated EGFR-mutated NSCLC. Among 114 patients assessed by blinded independent central review, complete responses were reported in 4.4% of cases and partial responses in 40%.

批准基于 TROPION-Lung05 和 TROPION-Lung01 试验的数据。在这些研究中，DATROWAY 在先前接受过治疗的 EGFR 突变型非小细胞肺癌患者中显示出 45% 的客观缓解率 (ORR)。在由盲态独立中心评审评估的 114 名患者中，4.4% 的病例报告了完全缓解，40% 报告了部分缓解。

The median duration of response (DoR) was 6.5 months. .

反应持续时间（DoR）的中位数为6.5个月。

The safety profile was evaluated in a pooled analysis of 125 patients across three trials. The most common side effects (occurring in 20% or more of patients) included stomatitis, nausea, fatigue, alopecia, constipation, and changes in blood parameters. Serious adverse reactions were reported in 26% of patients, with COVID-19, stomatitis, and pneumonia among the most frequent..

在三项试验的125名患者中进行了安全性分析。最常见的副作用（发生在20%或以上的患者中）包括口腔炎、恶心、疲劳、脱发、便秘和血液参数的变化。26%的患者报告了严重不良反应，其中最常见的是新冠肺炎、口腔炎和肺炎。

Continued approval may depend on further confirmation of clinical benefit.

持续批准可能取决于对临床益处的进一步确认。