Daiichi Sankyo and AstraZeneca?s supplemental Biologics License Application (sBLA) for DATROWAY (datopotamab deruxtecan-dlnk) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.
The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is June 2, 2026. The sBLA is based on results from the TROPION-Breast02 phase 3 trial presented at the 2025 European Society for Medical Oncology (#ESMO25) Congress. In the trial, DATROWAY demonstrated a statistically significant and clinically meaningful 5.0 month improvement in median overall survival (OS) (hazard ratio [HR]=0.79; 95% confidence interval [CI]: 0.64-0.98; p=0.0291) and a 43% reduction in risk of disease progression or death (HR=0.57; 95% CI: 0.47-0.69; p<0.0001) compared to investigator?s choice of chemotherapy as first-line treatment in this patient population.
DATROWAY was also associated with more robust and durable treatment responses, including an objective response rate (ORR) of 62.5% and duration of response (DoR) of 12.3 months, compared to an ORR of 29.3% and DoR of 7.1 months with chemotherapy. The sBLA is being reviewed under Project Orbis, which provides a framework for the concurrent submission and review of oncology medicines among participating international partners. This initiative is designed to bring effective cancer treatments to patients as early as possible.
Additional regulatory submissions for DATROWAY in breast and lung cancer are underway globally. The safety profile of DATROWAY was consistent with previous clinical trials of DATROWAY in breast cancer. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 33% and 29% of patients in the DATROWAY and chemotherapy arms, respectively.
The most common grade 3 or higher TRAEs were neutropenia (3%, 13%), stomatitis (8%, 0%), leukopenia (<1%, 4%), fatigue (3%, 3%), vomiting (1%, <1%), anemia (2%, 3%), alopecia (0%, <1%), peripheral neuropathy (0%, 2%), dry eye (1%, 0%), nausea (<1%, <1%), decreased appetite (<1%, <1%) and constipation (<1%, 0%). There was one grade 5 interstitial lung disease event in the DATROWAY arm adjudicated as drug-related by an independent committee. This event was characterized as grade 3 pneumonitis and cause of death was attributed to disease progression by the treating investigator.
