AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO: 4568) have submitted a filing to the U.S. Food and Drug Administration (FDA) for their antibody-drug conjugate (ADC) datopotamab deruxtecan, aimed at treating unresectable or metastatic HR-positive, HER2-negative breast cancer in adults who have previously received systemic therapy. A decision from the FDA is anticipated in the first quarter of 2025.
The submission is supported by preliminary data from a late-stage study that successfully met its primary endpoint of progression-free survival (PFS). Interim results also indicate a positive trend for the dual primary endpoint of overall survival (OS), suggesting that the TROP2-targeted therapy may offer advantages over traditional chemotherapy.
Additionally, datopotamab deruxtecan is under review in the U.S. for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC), further expanding its potential therapeutic applications.- Flcube.com
