AstraZeneca and Daiichi Sankyo announced that the US Food and Drug Administration (FDA) has approved Datroway(datopotamab deruxtecan) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.
The Priority Review approval is based on the landmark TROPION-Breast02 Phase III trial, where Datrowaydemonstrated a statistically significant and clinically meaningful 5.0-month improvement in median overall survival* compared to chemotherapy. Datroway reduced the risk of disease progression or death by 43% and delivered a robust objective response rate (ORR) of 64%, compared to just 30% with traditional chemotherapy.
As the first TROP2-directed antibody-drug conjugate (ADC) to show a median overall survival of two years in the 1st-line metastatic setting, Datroway has already been added to the NCCN Guidelines® as a Category 1 Preferred treatment option.
“For seven out of 10 patients with metastatic TNBC who cannot receive immunotherapy, chemotherapy was the only option,” said Arlene Brothers, Executive Director, Triple Negative Breast Cancer Foundation. “This approval means patients finally have a new standard of care at the outset of their treatment.”
The application was reviewed under Project Orbis, with concurrent regulatory reviews currently underway in the EU, China, Japan, and other global markets. Datroway is now approved for three indications in the US.
Written by : Pragna Biswas
Graphics by: Pramit Hazra
