Daiichi Sankyo and AstraZeneca (NYSE: ) received U.S. Food and Drug Administration approval for Datroway (datopotamab deruxtecan-dlnk) for treating adult patients with unresectable or metastatic triple negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy, according to a company statement.

The approval is based on results from the TROPION-Breast02 phase 3 trial, which showed Datroway demonstrated a 5.0-month improvement in median overall survival versus chemotherapy. Patients treated with Datroway had a median overall survival of 23.7 months compared to 18.7 months for those receiving chemotherapy.

Datroway reduced the risk of disease progression or death by 43% compared to chemotherapy. The median progression-free survival was 10.8 months for patients treated with Datroway versus 5.6 months for those treated with chemotherapy. The objective response rate was 64% with Datroway versus 30% with chemotherapy.

The safety profile showed the most common adverse reactions in 319 patients included stomatitis, increased amylase, nausea, alopecia, decreased hemoglobin, and decreased white blood cells. Serious adverse reactions occurred in 17% of patients, with one patient fatality attributed to interstitial lung disease/pneumonitis.

Datroway is a TROP2 directed antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with AstraZeneca. The drug is now approved for three indications in the U.S., including two for breast cancer and one for non-small cell lung cancer.

Triple negative breast cancer accounts for approximately 15% of all breast cancer cases, with an estimated 32,000 to 48,000 cases diagnosed in the U.S. in 2025. For approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy was previously the only approved first-line treatment.