LONDON - AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo have received U.S. Food and Drug Administration (FDA) acceptance for a Biologics License Application (BLA) for their drug datopotamab deruxtecan (Dato-DXd) for patients with a specific type of metastatic breast cancer. This application is for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have previously undergone systemic therapy.
The BLA submission is supported by results from the TROPION-Breast01 Phase III trial, which showed a statistically significant improvement in progression-free survival (PFS) for patients treated with datopotamab deruxtecan compared to those who received the investigator's choice of chemotherapy.
While overall survival (OS) data favored datopotamab deruxtecan, the results were not considered mature at the time of the data cut-off. The FDA's decision on the application is expected in the first quarter of 2025.
Datopotamab deruxtecan is an antibody-drug conjugate that targets TROP2, a protein frequently expressed in HR-positive, HER2-negative breast cancers and associated with aggressive tumor growth and poor prognosis. The safety profile of datopotamab deruxtecan in the TROPION-Breast01 trial was consistent with previous studies, with no new safety concerns identified.
This news comes as AstraZeneca and Daiichi Sankyo also have an additional BLA under review in the U.S. for datopotamab deruxtecan as a treatment for advanced nonsquamous non-small cell lung cancer (NSCLC), based on the TROPION-Lung01 Phase III trial. Regulatory submissions for the drug in both lung and breast cancer indications are in progress worldwide.
The acceptance of this BLA by the FDA marks a significant step for AstraZeneca and Daiichi Sankyo in their collaboration to develop and potentially commercialize new cancer treatments. The companies are actively working to provide datopotamab deruxtecan as a new treatment option to patients globally, pending regulatory approvals.
The information in this article is based on a press release statement from AstraZeneca.
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