Datopotamab Deruxtecan Biologics License Application Accepted in the U.S. for Patients with Previously Treated Advanced Nonsquamous Non-Small Cell Lung Cancer
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~ In a joint effort, Daiichi Sankyo and AstraZeneca have announced that their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the U.S. Food and Drug Administration (FDA). This application is seeking approval for the use of datopotamab deruxtecan in the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have previously received systemic therapy.

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) that is being jointly developed by Daiichi Sankyo and AstraZeneca. The Prescription Drug User Fee Act (PDUFA) date, which is the FDA's action date for its regulatory decision, has been set for December 20, 2024.

The BLA submission is based on data from the pivotal TROPION-Lung01 phase 3 trial, which was presented at a Presidential Symposium at the European Society for Medical Oncology (#ESMO23) 2023 Congress. In this trial, datopotamab deruxtecan showed a statistically significant improvement in progression-free survival (PFS) compared to docetaxel, the current standard of care, in patients with locally advanced or metastatic NSCLC who had received at least one prior line of therapy. While interim results also showed a trend towards improved overall survival (OS), this did not reach statistical significance at the time of data cut-off. However, in patients with nonsquamous NSCLC, datopotamab deruxtecan demonstrated both a clinically meaningful PFS benefit and a favorable OS trend. The trial is still ongoing and final analysis will include an assessment of OS. The safety profile of datopotamab deruxtecan was consistent with previous trials and no new safety concerns were identified.

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Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo, expressed the significance of this news, stating, "Today's news is an important step forward in our goal of creating new standards of care that have the potential to transform the treatment of patients with non-small cell lung cancer." He also added that they are looking forward to working closely with the FDA to bring datopotamab deruxtecan to patients.

Similarly, Susan Galbraith, MBBChir, PhD, Executive Vice President of Oncology R&D at AstraZeneca, emphasized the potential impact of datopotamab deruxtecan on patients with advanced nonsquamous NSCLC who have previously been treated. She stated that this novel treatment has the potential to offer an effective and tolerable alternative to conventional chemotherapy.

In addition to seeking approval for NSCLC, a parallel BLA for datopotamab deruxtecan based on results from the pivotal TROPION-Breast01 phase 3 trial is currently pending acceptance in the U.S. for the treatment of adult patients with metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer. The companies are also working towards additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer globally.

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