News Related to Invasive Disease Recurrence

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FDA accepts Genentech application for giredestrant in ESR1-mutated advanced breast cancer

May 19, 2026

The FDA has accepted the New Drug Application for giredestrant plus everolimus in ESR1-mutated, ER-positive, HER2-negative advanced breast cancer. The filing is based on Phase III evERA data showing reduced risk of disease progression or death versus standard-of-care endocrine therapy plus everolimus.

AstraZeneca, Daiichi Sankyo Seek Regulatory Approvals for Enhertu in Early Breast Cancer

Mar 10, 2026

The US FDA granted priority review and the European Medicines Agency validated applications for Enhertu as post-neoadjuvant treatment for HER2-positive early breast cancer, based on Phase III trial data showing 53% reduction in recurrence risk.