Datopotamab deruxtecan-dlnk approved for triple-negative breast cancer

On May 22, 2026, the Food and Drug Administration 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.

Full prescribing information for Datroway will be posted on Drugs@FDA.

Efficacy and Safety

Efficacy was evaluated in TROPION-Breast02 (NCT05374512), a multicenter, open-label, randomized trial of 644 patients with unresectable or metastatic TNBC who had not received prior chemotherapy or other systemic anti-cancer therapy for unresectable or metastatic breast cancer and who were not candidates for PD-1/PD-L1 inhibitor therapy. Patients were excluded for a history of ILD/pneumonitis requiring treatment with steroids, ongoing ILD/pneumonitis, or clinically significant corneal disease at screening.

Randomization was stratified by geographical region (United States, Canada and Europe or Rest of World), PD-L1 status (positive or negative) and disease-free interval (DFI) history (de novo or ≤12 months or >12 months). Patients were randomized (1:1) to receive either datopotamab deruxtecan-dlnk (N=323) or investigator’s choice of chemotherapy (N=321); paclitaxel (28%), nab-paclitaxel (54%), capecitabine (2.2%), eribulin (11%) or carboplatin (4.7%).

The major efficacy outcome measures were progression-free survival (PFS) as assessed by blinded independent central review (BICR) based on RECIST v1.1 and overall survival (OS). Additional efficacy outcome measures included confirmed overall response rate (ORR) by BICR. Median PFS was 10.8 months (95% CI: 8.6, 13.0) in the datopotamab deruxtecan-dlnk arm and 5.6 months (95% CI: 5.0, 7.0) in the chemotherapy arm (Hazard ratio 0.57 [95% CI: 0.47, 0.69]; p-value <0.0001). Median OS was 23.7 months (95% CI: 19.8, 25.6) and 18.7 months (95% CI: 16.0, 21.8) in the respective arms (Hazard ratio 0.79 [95% CI: 0.64, 0.98]; p-value 0.0290). Confirmed ORR was 64% (95% CI: 58, 69) and 30% (95% CI: 25, 36) in the respective arms.

The prescribing information includes warnings and precautions for interstitial lung disease and pneumonitis, ocular adverse reactions, stomatitis/oral mucositis, and embryo-fetal toxicity.

Recommended Dosage

The recommended datopotamab deruxtecan-dlnk dose is 6 mg/kg (up to a maximum of 540 mg for patients ≥90 kg) administered as an intravenous infusion once every three weeks (21-day cycle) until disease progression of unacceptable toxicity.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA), the Brazilian Health Regulatory Agency (ANVISA), Health Canada, Singapore’s Health Sciences Authority (HSA), and Switzerland’s Swissmedic. The applications may still be under review at the other regulatory agencies.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.

Follow the Oncology Center of Excellence on X: @FDAOncology.