Daiichi Sankyo and Merck announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to their investigational antibody-drug conjugate, raludotatug deruxtecan (R-DXd), for the treatment of adult patients with CDH6-expressing platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers who have previously received bevacizumab..

第一三共和默克宣布，美国食品药品监督管理局 (FDA) 已授予其在研抗体药物偶联物 raludotatug deruxtecan (R-DXd) 突破性疗法认定 (BTD)，用于治疗先前接受过贝伐单抗治疗的 CDH6 表达阳性的铂耐药型上皮性卵巢癌、原发性腹膜癌或输卵管癌成年患者。

Ovarian cancer remains a significant global health challenge, with more than 324,000 new cases diagnosed in 2022. Around 70–80% of patients with advanced disease relapse after platinum-based chemotherapy, and prognosis is particularly poor in cases of platinum resistance.

卵巢癌仍然是全球健康的重大挑战，2022年诊断出超过324,000例新病例。约70%-80%的晚期患者在铂类化疗后复发，而在铂类耐药的情况下预后尤其差。

CDH6, a cadherin family protein, is overexpressed in many ovarian cancers, especially high-grade serous carcinoma, and is found in about 65% of cases. There are currently no approved medicines targeting CDH6.

CDH6是一种钙黏蛋白家族蛋白，在许多卵巢癌中过表达，尤其是高级别浆液性癌，约65%的病例中可发现其表达。目前尚无获批的针对CDH6的药物。

Raludotatug deruxtecan is a potential first-in-class antibody-drug conjugate (ADC) targeting CDH6. It was discovered by Daiichi Sankyo and is being jointly developed with Merck. The FDA’s BTD programme is designed to speed up the development and review of medicines showing promising clinical results and addressing serious conditions with limited treatment options..

Raludotatug deruxtecan 是一种潜在的首创抗体药物偶联物 (ADC)，靶向 CDH6。它由第一三共发现，并与默克公司共同开发。FDA 的 BTD 项目旨在加速那些展示出良好临床效果并针对治疗选择有限的严重疾病的药物的开发和审查进程。

The designation was supported by findings from a phase 1 trial and ongoing results from the global REJOICE-Ovarian01 phase 2/3 study. Subgroup analyses of the phase 1 study have been presented at major scientific meetings, including the European Society for Medical Oncology and the Society for Gynaecologic Oncology. .

该指定得到了 1 期试验结果以及全球 REJOICE-Ovarian01 2/3 期研究持续结果的支持。1 期研究的亚组分析已经在主要科学会议上发表，包括欧洲肿瘤内科学会和妇科肿瘤学会。

This is the first BTD granted for raludotatug deruxtecan and the second for the Daiichi Sankyo and Merck partnership.

这是raludotatug deruxtecan获得的第一个突破性疗法认定（BTD），也是第一三共和默克合作的第二个突破性疗法认定。