Pharma major AstraZeneca (AZ) and partner Daiichi Sankyo have secured US market approval for Datroway (datopotamab deruxtecan) as a first-line treatment for patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are ineligible for PD-1/L1 therapy. This marks the first antibody-drug conjugate (ADC) approved in this setting globally. In 2025, the TROP2-targeting ADC was previously approved in China and the US for later-line HR+/HER2- breast cancer.

The approval is based on the Phase III TROPION-Breast02 trial, which demonstrated a statistically significant improvement in both overall survival (OS) and progression-free survival (PFS) compared to chemotherapy. The datopotamab deruxtecan arm achieved a median OS of 23.7 months (versus 18.7 months with chemotherapy) and a median PFS of 10.8 months (versus 5.6 months). TNBC accounts for approximately 15% of breast cancers and has a historically poor prognosis, with this approval addressing a significant unmet need in patients unsuitable for immunotherapy.

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