# Giredestrant PDUFA Event: Adjuvant treatment of ER-positive, HER2-negative early breast cancer

Canonical URL: https://biopharmsignal.com/pdufa-calendar/RHHBY/giredestrant-adjuvant-er-positive-her2-negative-early-breast-cancer

Ticker: RHHBY

Company: Roche Holdings AG

Event date: 2026-11-30

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA assigned a November 30, 2026 PDUFA goal date to the giredestrant NDA for adjuvant treatment of ER-positive, HER2-negative early br...

## Event Timeline

### November 30, 2026 — FDA decision expected

FDA assigned a November 30, 2026 PDUFA goal date to the giredestrant NDA for adjuvant treatment of ER-positive, HER2-negative early breast cancer.

[Roche — Giredestrant NDA acceptance and PDUFA date](https://www.roche.com/investors/updates/inv-update-2026-06-02)

### June 2, 2026 — FDA accepted the NDA with Priority Review

FDA accepted the giredestrant NDA under Priority Review based on the Phase 3 lidERA trial.

[Roche — Giredestrant NDA acceptance and Priority Review](https://www.roche.com/investors/updates/inv-update-2026-06-02)

### June 2026 — Phase 3 lidERA results supported the filing

In lidERA, adjuvant giredestrant reduced the risk of invasive disease recurrence or death by 30% versus standard endocrine therapy.

[Roche — lidERA efficacy results](https://www.roche.com/investors/updates/inv-update-2026-06-02)

## Regulatory Designations

- Priority Review FDA: [Roche — Giredestrant NDA acceptance and Priority Review](https://www.roche.com/investors/updates/inv-update-2026-06-02)

## Related Pages

- RHHBY PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/RHHBY.md

- RHHBY company profile: https://biopharmsignal.com/company/RHHBY.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

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