US Accepts Biologics License Application for Datopotamab Deruxtecan in Advanced HR-Positive, HER2-Negative Breast Cancer Post-Prior Treatment

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been officially accepted in the United States. This application targets the treatment of adult patients grappling with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer. These patients have undergone prior systemic therapy for their unresectable or metastatic condition. The anticipated regulatory decision by the US Food and Drug Administration (FDA), as per the Prescription Drug User Fee Act, is expected during the first quarter of 2025.

The basis for this BLA submission stems from the findings of the pivotal TROPION-Breast01 Phase III trial. In this trial, datopotamab deruxtecan showcased a statistically significant and clinically meaningful enhancement in progression-free survival (PFS) compared to chemotherapy chosen by the investigator. This was observed in patients with unresectable or metastatic HR-positive, HER2-negative breast cancer, who had previously received endocrine-based therapy and at least one other systemic therapy. Although interim results indicated a numerical advantage favoring datopotamab deruxtecan over chemotherapy for the dual primary endpoint of overall survival (OS), the data were not fully mature at the time of analysis. The trial continues, and further assessments of OS will be conducted in future analyses.

Datopotamab deruxtecan, a TROP2-directed DXd antibody drug conjugate (ADC), represents a collaborative effort between Daiichi Sankyo and AstraZeneca. It is meticulously engineered to target TROP2, with the aim of providing a novel therapeutic approach for patients with advanced breast cancer.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, emphasized the significance of this potential treatment option, particularly for patients who have developed resistance to endocrine therapy and face multiple rounds of chemotherapy.

Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo, highlighted the importance of this milestone in providing an alternative option to conventional chemotherapy for patients with previously treated HR-positive, HER2-negative breast cancer.

The TROPION-Breast01 trial results were presented at prestigious medical conferences, underscoring the clinical significance of datopotamab deruxtecan in the treatment landscape of breast cancer.

The safety profile of datopotamab deruxtecan remains consistent with previous observations, with no new safety concerns identified.

Furthermore, an additional BLA for datopotamab deruxtecan, based on results from the pivotal TROPION-Lung01 Phase III trial, is currently under review in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy.

In summary, the acceptance of the BLA for datopotamab deruxtecan represents a significant step forward in expanding treatment options for patients with advanced breast cancer, reaffirming the commitment of AstraZeneca and Daiichi Sankyo to address unmet medical needs in oncology.

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