AstraZeneca PLC (AZN) and Japan-based partner Daiichi Sankyo have received FDA approval for Enhertu (trastuzumab deruxtecan) as a first-line treatment for adult patients with unresectable or metastatic HER2-positive breast cancer in the United States. This approval, based on the phase III DESTINY-Breast09 study, allows for the combination use of Enhertu with Roche’s Perjeta (pertuzumab). A milestone payment of $150 million is due to Daiichi Sankyo following this approval.
The DESTINY-Breast09 study demonstrated a 44% reduction in the risk of disease progression when using the Enhertu-Perjeta combination compared to the standard treatment regimen. The median progression-free survival for patients on the Enhertu-Perjeta regimen was recorded at 40.7 months, compared to 26.9 months for the traditional regimen involving chemotherapy and Herceptin.
Enhertu is already approved in over 85 countries for the second-line treatment of HER2-positive breast cancer and has additional approvals for lung and gastric cancers. The FDA’s real-time oncology review program expedited Enhertu’s regulatory application.
