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FDA Accepts Roche NDA for Giredestrant in ESR1-Mutated Breast Cancer

Feb 20, 2026

The FDA has accepted Roche's New Drug Application for giredestrant plus everolimus to treat ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is based on phase III data showing significant reductions in disease progression risk.