# FDA Grants Priority Review to Giredestrant SERD for Early-Stage ER+ Breast Cancer

> fda · REPORTED · 2026-06-30

The FDA granted Priority Review to the NDA for giredestrant, an oral SERD, as adjuvant treatment for ER-positive, HER2-negative stage I-III breast cancer, with a PDUFA date of November 30, 2026. The application was supported by Phase 3 lidERA trial data showing a 30% reduction in the risk of invasive disease recurrence or death versus standard endocrine therapy.

About Roche/Genentech: Roche/Genentech is a global pharmaceutical company developing giredestrant as a next-generation oral selective estrogen receptor degrader for hormone receptor-positive breast cancer.

- Company: Roche/Genentech
- Sector: oncology
- Primary source: https://www.onclive.com/view/fda-flashback-breast-cancer-decisions-and-news-from-june-2026

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.