Biopharmaceutical companies AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted in the US, paving the way for this potential treatment for adult patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received previous systemic therapy. Datopotamab deruxtecan is a TROP2-directed DXd antibody-drug conjugate engineered by Daiichi Sankyo, and is jointly being developed by Daiichi Sankyo and AstraZeneca. The FDA is set to decide on the application by the first quarter of 2025.
This BLA is based on results from the TROPION-Breast01 Phase III trial, which demonstrated a significant improvement in progression-free survival compared to chemotherapy in patients with inoperable or metastatic HR-positive, HER2-negative breast cancer previously treated with endocrine-based therapy and a systemic therapy. The safety profile was consistent with other ongoing trials, with no new safety concerns identified.
According to Susan Galbraith, Executive Vice President, Oncology R&D at AstraZeneca, if approved, datopotamab deruxtecan would provide an efficient alternative to conventional chemotherapy for patients suffering from this type of advanced breast cancer.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
