Datroway datopotamab deruxtecan

Drug Class

TROP2-directed antibody-drug conjugate (ADC)

Mechanism

Binds to TROP2 on tumor cells and internalizes, releasing a cytotoxic topoisomerase I inhibitor payload to induce DNA damage and cell death.

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.

What This Means For Patients

Datroway is an advanced TROP2-targeted antibody-drug conjugate. It is approved by the FDA for metastatic triple-negative breast cancer and is accessible in Hainan Boao Lecheng under special pilot-zone regulations.

Regulatory Approvals

• FDA — approved (2026) — source

Pivotal Clinical Evidence

• TROPION-Breast02 — Bardia et al., Ann Oncol 2026 (NCT05374512) — DOI

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-approvals-and-safety-notifications
• https://www.astrazeneca.com/media-centre/press-releases.html