AstraZeneca Secures FDA Nod for New ADC Drug Datroway in Breast Cancer

Core Viewpoint - AstraZeneca's antibody-drug conjugate, datopotamab deruxtecan (Datroway), has received FDA approval for treating a specific type of breast cancer, marking a significant milestone in the company's oncology portfolio [1][2]. Drug Approval and Market Potential - Datroway is approved for unresectable or metastatic HR-positive, HER2-negative breast cancer in adult patients who have undergone prior endocrine-based therapy and chemotherapy [1]. - The FDA's approval follows a similar approval in Japan, based on phase III TROPION-Breast01 study data, which demonstrated a 37% reduction in the risk of disease progression or death compared to standard chemotherapy [2]. - AstraZeneca anticipates Datroway could achieve peak annual sales of at least $5 billion, contributing to the company's goal of reaching $80 billion in annual revenues by 2030 [3]. Clinical Development and Future Prospects - Datroway is the second ADC developed in partnership with Daiichi Sankyo, with ongoing evaluations in various cancer indications, including breast and lung cancers [7][8]. - The companies are conducting extensive clinical trials, including seven late-stage programs for lung cancer and five for breast cancer [8]. - A priority review by the FDA is underway for Datroway to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer, with a decision expected in Q3 2025 [9][10]. Additional Developments - AstraZeneca's cancer drug Calquence has received an expanded label for first-line treatment of mantle cell lymphoma, now approved in combination with chemoimmunotherapy for previously untreated patients [11][12]. - The approval for Calquence is based on phase III ECHO study data, showing a 27% reduction in the risk of disease progression or death compared to chemoimmunotherapy alone [12].