Datopotamab deruxtecan-dlnk (Datroway)

Key facts

• Datroway is not approved for every breast or lung cancer; biomarker status, prior treatment, and the exact disease setting matter.
• The first U.S. approval in January 2025 covered specified HR-positive, HER2-negative unresectable or metastatic breast cancer.
• A June 2025 accelerated approval covered specified previously treated EGFR-mutated non-small-cell lung cancer.
• A May 2026 approval covered specified unresectable or metastatic triple-negative breast cancer when PD-1/PD-L1 inhibitor therapy is not appropriate.

Why the exact indication matters

Datroway now has multiple FDA indications. A page or article describing only the 2025 breast cancer approval may be incomplete for a current 2026 search.

The treating team must match the cancer type, biomarkers, prior therapy, and other eligibility details to the current prescribing information.

Important safety context

The FDA label warns that Datroway can cause severe or fatal interstitial lung disease or pneumonitis. It also describes ocular adverse reactions, stomatitis, embryo-fetal harm, and other adverse reactions and monitoring requirements.

New or worsening breathing symptoms require prompt medical evaluation; this page is not a substitute for the current label or oncology care.

Primary sources

• FDA: Datroway approval for HR-positive, HER2-negative breast cancer — FDA approval notification dated January 17, 2025.
• FDA: oncology approval notifications — FDA listing that includes the June 2025 EGFR-mutated NSCLC approval.
• FDA: Datroway approval for specified triple-negative breast cancer — FDA approval notification dated May 22, 2026.
• FDA: Datroway prescribing information — Current FDA label with indications, warnings, dosing, and adverse reactions.