News Related to ER-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

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FDA Accepts Giredestrant Application for ESR1-Mutated Advanced Breast Cancer

Mar 10, 2026

The FDA has accepted Roche's new drug application for giredestrant plus everolimus to treat ER-positive, HER2-negative, ESR1-mutated advanced breast cancer following prior endocrine therapy, with a decision expected by December 18, 2026.

FDA Reviews Giredestrant Plus Everolimus for ESR1-Mutated ER-Positive Breast Cancer

Feb 20, 2026

The FDA has accepted a new drug application for giredestrant plus everolimus for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer, with a decision expected by December 18, 2026. The phase 3 evERA study showed a 62% reduction in disease progression or death risk in ESR1-mutated patients.