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Genentech’s Giredestrant Moves Forward for ER+, ESR1-Mutated Advanced Breast Cancer Following FDA NDA Acceptance
The FDA has accepted Genentech’s New Drug Application for giredestrant, an oral SERD, for ER+/HER2- advanced breast cancer with ESR1 mutations. This investigational drug targets a key resistance mechanism, potentially offering a less toxic alternative to chemotherapy for approximately 40% of patients with this mutation. Data from the Phase III EMERALD trial will guide the FDA’s review, which could lead to a significant advancement in precision oncology.