FDA Approval Summary: Datopotamab Deruxtecan-dlnk for Treatment of Patients with Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer.

Approval was based on results from TROPION-Breast01 (TB01), a multicenter, randomized, open-label trial comparing Dato-DXd with investigator's choice of chemotherapy (ICC).

批准是基于TROPION-Breast01（TB01）的结果，这是一项多中心、随机、开放标签的试验，比较了Dato-DXd与研究者选择的化疗（ICC）。

The trial was designed with dual primary endpoints: progression-free survivalassessed by blinded independent central review according to RECIST v1.1 and overall survival(OS).

该试验设计了两个主要终点：通过根据RECIST v1.1标准的盲法独立中心审查评估的无进展生存期（PFS）和总生存期（OS）。

TB01 demonstrated a 2-month improvement in median progression-free survivalfor Dato-DXd compared with ICC (6.9 vs. 4.9 months, respectively; stratified HR, 0.63; 95% confidence interval, 0.52-0.76; P < 0.0001).

TB01显示，与ICC相比，Dato-DXd的中位无进展生存期提高了2个月（分别为6.9个月对比4.9个月；分层风险比为0.63；95%置信区间为0.52-0.76；P < 0.0001）。

The OS endpoint was not met; at the final analysis of OS, the median OS was 18.6 months in the Dato-DXd arm and 18.3 months in the ICC arm (HR, 1.01; 95% confidence interval, 0.83-1.22).

总生存期终点未达到；在总生存期的最终分析中，Dato-DXd组的中位总生存期为18.6个月，而ICC组为18.3个月（风险比，1.01；95%置信区间，0.83-1.22）。

Although there was no OS improvement, Dato-DXd was also not associated with a clear trend toward potential detriment compared with ICC.

尽管没有总生存期的改善，但Dato-DXd与ICC相比也没有显示出明显的潜在危害趋势。

The most commonly reported adverse reactions (≥20%) with Dato-DXd were stomatitis, nausea, fatigue, alopecia, constipation, dry eye, keratitis, and vomiting.

与Dato-DXd相关的最常见不良反应（发生率≥20%）包括口腔炎、恶心、疲劳、脱发、便秘、干眼症、角膜炎和呕吐。

Overall, the favorable benefit-risk profile for Dato-DXd supported its approval for the intended indication.

总体而言，Dato-DXd的良好效益风险比支持了其针对预期适应症的批准。