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FDA Sets Review Date for Datopotamab Deruxtecan in Breast Cancer


Datopotamab deruxtecan, which is being reviewed to treat adults with HR-positive, HER2-negative breast cancer, has an FDA target date in the first quarter of 2025. Datopotamab deruxtecan also is under FDA review for non-small cell lung cancer.

The FDA has set the Prescription Drug User Fee Act date for the first quarter of 2025 for a decision on datopotamab deruxtecan, which is being reviewed to treat adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer. If approved, it would be indicated for those who have received prior systemic therapy for unresectable or metastatic disease.

More than 275,000 breast cancer cases were diagnosed in the United States in 2022, according to the World Health Organization. HR-positive, HER2-negative breast cancer is the most common subtype, accounting for more than 65% of diagnosed cases, according to the National Cancer Institute.

Datopotamab deruxtecan is a TROP2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo. TROP2 is overly expressed in breast cancer and plays a role in tumor growth and metastasis.

Susan Galbraith

Susan Galbraith

“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,” Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, said in a news release.

The biologics license application is based on results from the pivotal TROPION-Breast01 phase 3 trial in which datopotamab deruxtecan. In the trial, datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with chemotherapy, one of the primary end points. For second primary end point of overall survival (OS), interim results favored datopotamab deruxtecan over chemotherapy but were not mature at the time of data cutoff. The trial is ongoing and overall survival will be assessed at future analyses.

The trial found that datopotamab deruxtecan reduced the risk of disease progression or death by 37%, providing a two-month median progression-free survival benefit. Results also showed a confirmed objective response rate (ORR) of 36.4% in patients treated with datopotamab deruxtecan compared with an ORR of 22.9% with chemotherapy.

The most common grade 3 or higher treatment-related adverse events were neutropenia, stomatitis, fatigue and anemia. In the datopotamab deruxtecan arm, the all-grade interstitial lung disease (ILD) rate was low and the majority of events were low grade.

These results from TROPION-Breast01 were presented during a Presidential Symposium at the European Society for Medical Oncology Congress in October 2023 and in an oral presentation at the 2023 San Antonio Breast Cancer Symposium.

A separate biologics license application is under review for datopotamab deruxtecan to treat adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. The action date for this indication is in the fourth quarter of 2024.

The NSCLC application is based on data from the TROPION-Lung01 phase 3 trial in which datopotamab deruxtecan reduced the risk of disease progression or death by 25% in overall population and by 37% in patients with non-squamous tumor. Datopotamab deruxtecan had demonstrated improvement in progression-free survival compared with docetaxel, the current standard of care, in patients with locally advanced or metastatic non-small cell lung cancer treated with at least one prior line of therapy.

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