DATROWAY (datopotamab deruxtecan-dlnk) has been approved by the Food and Drug Administration for treating adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.

The approval is based on results from the TROPION-Breast02 Phase III trial, which demonstrated a statistically significant 5.0-month improvement in median overall survival compared to chemotherapy. The trial showed DATROWAY achieved a median overall survival of approximately two years with a hazard ratio of 0.79 and reduced the risk of disease progression or death by 43%.

DATROWAY is a TROP2-directed antibody drug conjugate developed jointly by AstraZeneca (LSE/STO/NYSE: AZN) and Daiichi Sankyo. The drug showed an objective response rate of 64% compared to 30% with chemotherapy in the clinical trial.

The approval follows Priority Review by the FDA and was reviewed under Project Orbis, which provides concurrent submission and review among international partners. Additional reviews are ongoing in Australia, Canada, Singapore, Switzerland, the European Union, China and Japan.

DATROWAY has been included in the NCCN Clinical Practice Guidelines as a Category 1 Preferred first-line treatment option for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy.

The drug is now approved for three indications in the United States, 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 11,000 patients receiving first-line treatment annually in the US.