European Drug Regulator Approves AstraZeneca's Two Flagship Cancer Drugs For Breast And Lung Cancer Settings

The European Commission on Friday approved AstraZeneca Plc (NASDAQ:AZN) and Daiichi Sankyo's (OTC:DSKNY) Enhertu (trastuzumab deruxtecan) as a monotherapy for a type of breast cancer.

The approval covers adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment.

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The approval is based on results from the DESTINY-Breast06 Phase 3 trial.

In the trial, Enhertu showed a 38% reduction in the risk of disease progression or death versus chemotherapy in patients with ...