Pharma Focus Asia

Datopotamab Deruxtecan Biologics License Application Accepted for Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer in the U.S.

Tuesday, April 02, 2024

Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have jointly submitted a Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) to the U.S. regulatory authorities. This submission aims to seek approval for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative breast cancer who have undergone prior systemic therapy.

Datopotamab deruxtecan is a specially designed TROP2 directed DXd antibody drug conjugate (ADC) developed through collaboration between Daiichi Sankyo and AstraZeneca. The Prescription Drug User Fee Act (PDUFA) date, which marks the FDA's decision deadline, is scheduled for January 29, 2025.

The BLA submission is based on data from the pivotal TROPION-Breast01 phase 3 trial. Results from this trial, presented at the 2023 European Society for Medical Oncology (ESMO23) Congress and the 2023 San Antonio Breast Cancer Symposium (SABCS23), showed a significant improvement in progression-free survival (PFS) compared to chemotherapy in patients with previously treated HR positive, HER2 negative breast cancer. While interim results for overall survival (OS) favored datopotamab deruxtecan over chemotherapy, final OS results are pending further analysis as the trial continues.

The safety profile of datopotamab deruxtecan remains consistent with previous trials, with no new safety concerns identified. The most common grade 3 or higher treatment-related adverse events included neutropenia, stomatitis, fatigue, and anemia.

Ken Takeshita, MD, Global Head of R&D at Daiichi Sankyo, expressed optimism about providing an alternative to conventional chemotherapy for patients with advanced breast cancer. Susan Galbraith, MBBChir, PhD, Executive Vice President of Oncology R&D at AstraZeneca, highlighted the potential of datopotamab deruxtecan to offer patients a more effective and better-tolerated treatment option.

Another BLA for datopotamab deruxtecan based on the TROPION-Lung01 trial is under review in the U.S. for treating adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have undergone prior systemic therapy. Furthermore, regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.

TROPION-Breast01 is a global phase 3 trial assessing datopotamab deruxtecan versus single-agent chemotherapy in patients with HR positive, HER2 negative breast cancer who have progressed on prior treatments. The trial enrolled over 700 patients across various regions.

HR positive, HER2 negative breast cancer is the most common subtype of breast cancer, comprising over 65% of diagnosed cases. Standard treatment typically involves endocrine therapy, but resistance often develops, necessitating additional treatment options.

Datopotamab deruxtecan (Dato-DXd) is an investigational ADC targeting TROP2. It is part of Daiichi Sankyo's oncology pipeline and AstraZeneca's ADC scientific platform. The drug consists of a humanized anti-TROP2 monoclonal antibody attached to a topoisomerase I inhibitor payload via cleavable linkers.

A robust global clinical development program, comprising more than 20 trials, is ongoing to evaluate the efficacy and safety of datopotamab deruxtecan across multiple cancer types, including NSCLC and breast cancer subtypes.



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