On 27 and 28 January 2025, AstraZeneca and Daiichi Sankyo announced that the US FDA has approved Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer.
The FDA granted priority review to the companies’ supplemental Biologics Licence Application for Enhertu® in October 2024.
Enhertu® will be considered for reimbursement by Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) at its May 2025 meeting. In December 2024, New Zealand’s Pharmac announced additional funding for Enhertu® for people with HER2-positive metastatic breast cancer. In November 2024, China added Enhertu® to its state-run health insurance scheme.