Datroway datopotamab deruxtecan
德达博妥单抗
Drug Class
TROP2-directed antibody-drug conjugate (ADC)靶向TROP2的抗体偶联药物 (ADC)
Mechanism
Binds to TROP2 on tumor cells and internalizes, releasing a cytotoxic topoisomerase I inhibitor payload to induce DNA damage and cell death.特异性结合肿瘤细胞表面的TROP2蛋白并被内吞,在细胞内释放细胞毒性拓扑异构酶I抑制剂,从而导致DNA损伤和细胞死亡。
Approved Indication
FDA-approved for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.FDA批准用于治疗不适合接受PD-1/PD-L1抑制剂治疗的不可切除或转移性三阴性乳腺癌 (TNBC) 成人患者。
What This Means For Patients
Datroway is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.Datroway(德达博妥单抗)目前未通过中国大陆零售药房渠道销售。优健云可协助安排购买渠道,药品由香港采购发货;如有需要,可协调来华后的临床用药支持。具体供应及患者适用性以医疗预检评估为准。
Regulatory Approvals
- FDA — Approved (2026) — Sources
Pivotal Clinical Evidence
- TROPION-Breast02 — Bardia et al., Ann Oncol 2026 (NCT05374512) — Sources