# FDA Accepts Roche NDA for Giredestrant in Early-Stage ER-Positive Breast Cancer Under Priority Review

> fda · REPORTED · 2026-06-02

The FDA accepted Roche's New Drug Application for giredestrant, an investigational oral selective estrogen receptor degrader (SERD), as adjuvant treatment for adults with ER-positive, HER2-negative, stage I-III breast cancer, with a decision expected by November 30, 2026. Giredestrant is described as the first oral SERD with positive Phase 3 results in the curative setting.

About Roche (giredestrant): Roche's giredestrant is an oral next-generation SERD in development for early-stage ER-positive, HER2-negative breast cancer, targeting the estrogen receptor to prevent cancer recurrence after primary treatment.

- Company: Roche (giredestrant)
- Sector: oncology
- Primary source: https://www.roche.com/media/releases/med-cor-2026-06-02

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