Enhertu approved in USA for 1st-line HER2+ metastatic BC

AstraZeneca (LSE: AZN) and Daiichi Sankyo’s (TYO: 4568) Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the USA for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by a Food and Drug Administration (FDA)-approved test.

The approval follows priority review and breakthrough therapy designation by the FDA and is based on the results of the DESTINY-Breast09 Phase III trial.

Dave Fredrickson, executive vice president, Oncology Hematology Business Unit at AstraZeneca, said: “With this approval, we are bringing Enhertu to the earliest setting for HER2-positive metastatic breast cancer, where optimising efficacy has an important impact on long‑term outcomes. The treatment approach with Enhertu plus pertuzumab in DESTINY-Breast09 sets a new benchmark of more than three years without disease progression or death for patients in this setting.”