Daiichi Sankyo and AstraZeneca’s application for ENHERTU has been accepted for Priority Review by the US Food and Drug Administration (FDA). This treatment targets adult patients with HER2 low or ultralow unresectable or metastatic breast cancer who have undergone prior endocrine therapy.
ENHERTU, an antibody-drug conjugate, was jointly developed by Daiichi Sankyo and AstraZeneca. The FDA grants Priority Review status to promising therapies with the potential for significant improvements in treatment outcomes. The Prescription Drug User Fee Act (PDUFA) date for the FDA’s decision is February 1, 2025.
The application is supported by data from the DESTINY-Breast06 clinical trial, which showed that ENHERTU reduced the risk of disease progression or death by 37% in the overall population and improved median progression-free survival from 8.1 months to 13.2 months compared to chemotherapy. Results were consistent across HER2 low and ultralow subgroups.
The safety profile of ENHERTU in DESTINY-Breast06 was generally consistent with previous clinical trials. The most common grade 3 or higher side effects included neutropenia, leukopenia, and anemia. Interstitial lung disease (ILD) or pneumonitis occurred in 11.3% of patients, with most cases being low-grade. There were no grade 4 or 5 ILD events.
This application underscores the potential of ENHERTU in addressing the need for improved treatment options for patients with HR-positive, HER2 low, or ultralow breast cancer, which represents approximately 85-90% of breast cancer cases.
Source link: http://www.businesswire.com/news/home/20240930807595/en/ENHERTU%C2%AE-Granted-Priority-Review-in-the-U.S.-for-Patients-with-HER2-Low-or-HER2-Ultralow-Metastatic-Breast-Cancer-Who-Have-Received-at-Least-One-Line-of-Endocrine-Therapy
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
