FDA Approves Enhertu Plus Pertuzumab for First-Line HER2-Positive Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) has approved Enhertu in combination with pertuzumab for the first-line treatment of patients with HER2-positive metastatic breast cancer. This marks the first new treatment option for this indication in over a decade.
AstraZeneca and Daiichi Sankyo announced that their medication Enhertu (trastuzumab deruxtecan), in combination with pertuzumab, has received U.S. Food and Drug Administration (FDA) approval for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
The approval, based on results from the DESTINY-Breast09 Phase III trial, represents a significant advancement. The trial demonstrated that Enhertu combined with pertuzumab reduced the risk of disease progression or death by 44% compared to the previous standard of care, THP (a taxane, trastuzumab, and pertuzumab). Median progression-free survival (PFS) exceeded three years with the new combination, reaching 40.7 months, compared to 26.9 months for THP.
"With this approval, we are bringing Enhertu to the earliest setting for HER2-positive metastatic breast cancer, where optimizing efficacy has an important impact on long-term outcomes," stated Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit at AstraZeneca. He added that the treatment sets a new benchmark of over three years without disease progression or death for patients in this setting.
Enhertu is a HER2-directed antibody-drug conjugate (ADC) developed by Daiichi Sankyo and jointly commercialized by AstraZeneca and Daiichi Sankyo. This U.S. approval triggers a $150 million milestone payment from AstraZeneca to Daiichi Sankyo.