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# Roche’s Giredestrant Promising Data in Early Breast Cancer
- URL: https://www.fdaweb.com/roches-giredestrant-promising-data-in-early-breast-cancer/
- Published: 2025-11-18T12:00:00.000Z
- Updated: 2026-09-14T15:26:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160239

Roche says its investigational selective estrogen receptor degrader (SERD) giredestrant significantly improved invasive disease-free survival in people with early-stage, ER-positive/HER2-negative breast cancer, marking the first time an oral SERD has shown superiority to standard endocrine therapy in the adjuvant setting.

The Phase 3 lidERA trial reached its primary endpoint at a planned interim analysis, demonstrating giredestrant’s statistically significant and clinically meaningful benefit over standard endocrine monotherapy, according to the company. Overall survival data remain immature, though Roche reported a positive trend, and safety data were consistent with prior studies and showed no unexpected signals, it adds.

Roche says giredestrant is being studied across five company-sponsored Phase 3 trials spanning early-stage, endocrine-sensitive, and resistant advanced disease, including combinations with CDK4/6 inhibitors, everolimus, and Phesgo (pertuzumab, trastuzumab, and hyaluronidase).

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