FDA accepts BLA for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for breast cancer treatment
Betsy Goodfellow | April 2, 2024 | News story | Research and Development | AstraZeneca, Daiichi Sankyo, FDA, Oncology, bla, breast cancer
AstraZeneca and Daiichi Sankyo have announced that their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-Dxd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have had prior systemic therapy for unresectable or metastatic disease.
The US Food and Drug Administration (FDA) has granted this a Prescription Drug User Fee Act date during the first quarter of 2025.
This BLA is based on results from the TROPION-Breast01 phase 3 trial which demonstrated the drug’s statistically significant and clinically meaningful improvement in progression free survival (PFS) compared to chemotherapy in patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who had previously been treated with endocrine based therapy and one systemic therapy. The trial is ongoing, with overall survival (OS) results currently immature.
Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca, commented: “Despite marked progress in the treatment of HR-positive, HER2-negative breast cancer, most patients with advanced disease develop endocrine resistance and face the prospect of one or several lines of chemotherapy. If approved, datopotamab deruxtecan has the potential to provide these patients an efficacious and better tolerated alternative to conventional chemotherapy.”
Betsy Goodfellow
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