FDA Expands Approval for Enhertu®
On May 5, 2022, the FDA expanded approval for trastuzumab deruxtecan (Enhertu®, AstraZeneca and Daiichi Sankyo) for the treatment of patients with HER2-positive MBC who have received one previous anti-HER2 treatment. This new approval is based on results from the DESTINY-Breast03 phase III trial. The previous approval was for patients with HER2-positive MBC who had received two previous anti-HER2 treatments.
- Healio: FDA Expands Enhertu Approval for HER2-Positive MBC
- AstraZeneca Press Release: Enhertu Approved in US for HER2-Positive MBC