# Giredestrant + everolimus PDUFA Event: ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer

Canonical URL: https://biopharmsignal.com/pdufa-calendar/RHHBY/giredestrant-everolimus-esr1-mutated-advanced-breast-cancer

Ticker: RHHBY

Company: Roche Holdings AG

Event date: 2026-12-18

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA set December 18, 2026 as the PDUFA action date for giredestrant plus everolimus.

## Event Timeline

### December 18, 2026 — FDA decision expected

FDA set December 18, 2026 as the PDUFA action date for giredestrant plus everolimus.

[Roche — NDA acceptance and PDUFA date](https://www.roche.com/media/releases/med-cor-2026-02-20)

### February 20, 2026 — FDA accepted the NDA

FDA accepted Roche’s NDA for giredestrant plus everolimus in the post-endocrine-therapy setting.

[Roche — NDA acceptance](https://www.roche.com/media/releases/med-cor-2026-02-20)

### February 20, 2026 — evERA Phase 3 data supported the filing

In the ESR1-mutated population, giredestrant plus everolimus reduced the risk of progression or death by 62% versus standard endocrine therapy plus everolimus.

[Roche — evERA data summary](https://www.roche.com/media/releases/med-cor-2026-02-20)

## 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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