Datroway joins Trodelvy for frontline TNBC in the EU

AstraZeneca and Daiichi Sankyo's TROP2-targeting drug Datroway has been approved by the European Commission for some previously untreated patients with metastatic triple-negative breast cancer (TNBC), its second indication.

The approval covers the use of Datroway (datopotamab deruxtecan) as a first-line monotherapy for TNBC patients who are not candidates for PD-1/PD-L1 inhibitor-based immunotherapy. The antibody-drug conjugate (ADC) is also approved in the EU as a second-line therapy for unresectable or metastatic HR-positive, HER2-negative breast cancer.

The new indication is far from niche – around 70% of patients with metastatic TNBC are not eligible for this type of immunotherapy – and Datroway was the first drug in the TROP2 class to move into the frontline setting in this form of breast cancer when it was approved in the US last year.

It has since been joined in the US by Gilead Sciences' rival TROP2 ADC, Trodelvy (sacituzumab govitecan), which has been cleared as a monotherapy for TNBC patients ineligible for PD-1/PD-L1 inhibitors – an indication approved in the EU earlier this month – and as a combination with the latter drugs for those with PD-L1-positive tumours. The latter use was recommended for EU approval last week.

AZ and Daiichi say their drug is the only TROP2 therapy that has been shown to improve overall survival (OS) in PD-1/PD-L1-ineligible TNBC.

The expansion of Datroway's label comes on the back of the TROPION-Breast02 trial, in which treatment with the ADC led to a statistically significant five-month improvement in median OS and a 43% reduction in patients' risk of disease progression or death compared to a control group treated with chemotherapy.

"Every year, more than 80,000 people in Europe are diagnosed with [TNBC], a disease that often affects younger women and has limited treatment options in the metastatic setting," said AZ's head of oncology and haematology, Dave Fredrickson.

"Today's approval of Datroway brings an antibody drug conjugate with a differentiated clinical profile underpinned by a strong survival benefit to people with this aggressive disease," he added.

Global sales of Datroway, recorded by AZ and Daichi Sankyo, were $102 million in the first quarter of this year – a more than 10-fold increase on the same period of 2025 – while Gilead recorded a 37% rise to $402 million for Trodelvy.