On May 22, 2026, the FDA approved datopotamab deruxtecan-dlnk (Datroway) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. The approval was supported by the TROPION-Breast02 trial, a multicenter, open-label, randomized study that enrolled 644 patients with previously untreated, unresectable or metastatic TNBC. Patients were randomized to receive datopotamab deruxtecan-dlnk or investigator’s choice of chemotherapy, which included paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin.
The major efficacy outcomes were progression-free survival (PFS) and overall survival (OS). Datopotamab deruxtecan-dlnk improved median PFS to 10.8 months compared with 5.6 months with chemotherapy, and median OS was 23.7 months versus 18.7 months, respectively. Confirmed overall response rate was also higher with datopotamab deruxtecan-dlnk at 64% compared with 30% for chemotherapy.
The recommended dose is 6 mg/kg intravenously once every 3 weeks, up to a maximum of 540 mg for patients weighing at least 90 kg, until disease progression or unacceptable toxicity. The prescribing information includes warnings and precautions for interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis/oral mucositis, and embryo-fetal toxicity. This review was conducted under Project Orbis, with collaboration from several international regulatory agencies.
Source
- US Food and Drug Administration. FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer. May 22, 2026. Accessed June 2, 2026. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer