AstraZeneca Enhertu Secures US FDA Approval for HER2-Low Breast Cancer


The US Food and Drug Administration (FDA) has approved Enhertu of AstraZeneca and Daiichi Sankyo for the treatment of adult patients with metastatic HER2-low breast cancer, who have received a prior chemotherapy in the metastatic setting during six months of completing adjuvant chemotherapy.

Enhertu is a specifically designed HER2-directed antibody drug conjugate (ADC), that has been jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The approval by US FDA was based on the results from the DESTINY-Breast04 Phase 3 trial. In the trial, Enhertu has decreased the risk of the disease progression or death by 50 percent against the choice of chemotherapy of physicians of chemotherapy with hormone receptor.

Shanu Modi, medical oncologist at Memorial Sloan Kettering Cancer Center, US, said around half of all patients with breast cancer have tumours that are HER2-low, which has previously been classified as HER2-negative, and has not had effective treatment options with HER2-targeted medicines.

Based on the results of the DESTINY-Breast04 trial, clinicians are starting to differentiate levels of HER2 expression, and also redefine how metastatic breast cancer is classified with a distinct HER2-low patient population, which might be eligible for trastuzumab deruxtecan.

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Dave Fredrickson, executive vice president of Oncology Business Unit at AstraZeneca, said the rapid approval of Enhertu in HER2-low metastatic breast cancer by the US FDA highlighting the urgency to bring this transformational medicine to patients as fast as possible.