FDA Approves Datroway as First‑Line Option for Immunotherapy‑Ineligible Triple‑Negative Breast Cancer
Regulators cleared the TROP2‑targeting antibody‑drug conjugate after Phase III data showed a meaningful survival benefit versus chemotherapy, creating a new first‑line choice for patients who cannot receive PD‑1/PD‑L1 therapy.
Overview
- The FDA approved Datroway (datopotamab deruxtecan) on May 22, 2026, for first‑line treatment of unresectable or metastatic triple‑negative breast cancer in patients who are not candidates for PD‑1/PD‑L1 immunotherapy.
- Approval was based on the Phase III TROPION‑Breast02 trial, in which Datroway improved median overall survival by five months and cut the risk of progression or death by 43% compared with investigator‑choice chemotherapy.
- TROPION‑Breast02 also reported higher tumor shrinkage and disease control with Datroway, with an objective response rate of 64% versus 30% for chemotherapy and median progression‑free survival roughly 10.8 months versus 5.6 months.
- Safety data showed common side effects such as stomatitis, nausea, alopecia and low blood counts, serious adverse reactions in 17% of patients and one treatment‑related death from interstitial lung disease or pneumonitis in the trial.
- Datroway is already on the U.S. market for other tumor types and companies have filed for expanded approvals in multiple countries, a move that could broaden access and further establish antibody‑drug conjugates as a treatment class in solid tumors.