FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer
Regulatory approval: On May 22, 2026, the FDA approved datopotamab deruxtecan-dlnk (Datroway) for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. Approval was supported by TROPION-Breast02, where datopotamab deruxtecan-dlnk improved PFS (10.8 vs 5.6 months; HR 0.57) and OS (23.7 vs 18.7 months; HR 0.79) versus investigator’s choice chemotherapy. Label includes warnings for ILD/pneumonitis, ocular adverse reactions, stomatitis/oral mucositis, and embryo-fetal toxicity.
FDA approval (May 22, 2026)
The US Food and Drug Administration (FDA) approved datopotamab deruxtecan-dlnk (Datroway; Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
Key trial evidence
Approval was based on TROPION-Breast02 (NCT05374512), a multicenter, open-label, randomized trial (N=644) in patients with unresectable/metastatic TNBC who had not received prior chemotherapy or other systemic anti-cancer therapy for unresectable/metastatic disease and were not PD-1/PD-L1 inhibitor candidates. Key exclusions included prior ILD/pneumonitis requiring steroids, ongoing ILD/pneumonitis, or clinically significant corneal disease.
Patients were randomized 1:1 to datopotamab deruxtecan-dlnk (N=323) or investigator’s choice chemotherapy (N=321; paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin). Major endpoints were PFS (BICR, RECIST v1.1) and OS.
- Median PFS: 10.8 vs 5.6 months (HR 0.57; p<0.0001)
- Median OS: 23.7 vs 18.7 months (HR 0.79; p=0.0290)
- Confirmed ORR (BICR): 64% vs 30%
Safety and dosing (label highlights)
Warnings/precautions include interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis/oral mucositis, and embryo-fetal toxicity. Recommended dose: 6 mg/kg IV every 3 weeks (max 540 mg for patients ≥90 kg) until progression or unacceptable toxicity.
The review was conducted under Project Orbis; applications may still be under review by other agencies.