The approval by the Food and Drug Administration was based on the results from the DESTINY-Breast04 Phase III trial.
Median overall survival of 23.4 months was seen in patients treated with Enhertu versus 16.8 months in those treated with chemotherapy, a 36% reduction.
Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, said: “The rapid approval of Enhertu in HER2-low metastatic breast cancer by the FDA underscores the urgency to bring this transformational medicine to patients as quickly as possible. Patients with HER2-low tumors, who are identified through existing HER2 testing methods, will now have the opportunity to be treated based upon their HER2 status.”
The DESTINY-Breast04 Phase III trial results were presented at the presidential plenary session of the 2022 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine (NEJM).
The safety profile of Enhertu was consistent with previous clinical trials with no new safety concerns identified.
Regulatory applications for Enhertu are also currently under review in Europe, Japan and several other countries based on the DESTINY-Breast04 results.
AstraZeneca employs about 1,500 in administrative, logistics and manufacturing in northern Delaware.