Datroway granted priority review in the US as 1st-line treatment for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy

CAR-T Digest - August 2020

Weekly Digest - February 2026

03 February 2026: Datroway granted priority review in the US as 1st-line treatment for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy

Datroway has taken a major regulatory step in the US, with the FDA accepting and granting Priority Review to the supplemental BLA for its use as a 1st-line treatment in unresectable or metastatic triple-negative breast cancer patients who are not candidates for immunotherapy, a population that today relies almost exclusively on chemotherapy
This decision is based on compelling Phase 3 evidence from TROPION-Breast02, where Datroway became the only therapy to demonstrate a statistically significant and clinically meaningful overall survival benefit versus chemotherapy in this hard-to-treat setting, reinforcing its potential to shift the treatment paradigm
Beyond survival, the trial painted a broader efficacy story: Datroway delivered a 5-month median OS improvement, reduced the risk of disease progression or death by 43%, and nearly doubled response durability, with a 62.5% ORR and a median DoR of 12.3 months, results that stood out even in a cohort enriched for aggressive disease and poor prognostic features
The FDA review is being conducted under Project Orbis, highlighting a coordinated global effort to accelerate patient access, with a regulatory action date expected in Q2 2026, an important milestone given that around 70% of metastatic TNBC patients are ineligible for PD-1/PD-L1 inhibitors
For AstraZeneca and Daiichi Sankyo, Datroway’s Priority Review underscores the growing impact of next-generation DXd ADCs in earlier lines of therapy, positioning this TROP2-directed conjugate as a potential new standard of care and a flagship program in the rapidly evolving ADC landscape