- Start
- Nov 30, 202675% CONFIDENCEfrom the source
FDA Decision Due on Roche's Giredestrant for Early Breast Cancer
- The FDA accepted Roche's application for giredestrant as adjuvant treatment of ER-positive, HER2-negative stage I to III breast cancer under Priority Review, with a decision expected by 30 November 2026[1][4]
- In the phase 3 lidERA trial of more than 4,100 patients, giredestrant cut the risk of invasive disease recurrence or death by 30% versus standard endocrine therapy (HR 0.70)[1][3]
- At three years 92.4% of patients on giredestrant were alive and free of invasive disease, against 89.6% on standard therapy[1]
- Treatment discontinuation was 5.3% on giredestrant versus 8.2% on standard therapy; overall survival data were still immature[1]
- A separate application, giredestrant with everolimus for ESR1-mutated advanced breast cancer, has a decision expected in December 2026[1]
Notable features
- An oral selective oestrogen receptor degrader (SERD) and full antagonist: it stops oestrogen binding to the receptor and triggers the receptor's breakdown[1]
- Would be the first oral SERD with positive phase 3 results in the curative, early-stage setting[1][4]
- ER-positive disease is about 70% of breast cancers, and up to a third of patients relapse on or after adjuvant endocrine therapy[1]
References 478% CONFIDENCE
The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.
- [1]75%roche.com/media/releases/med-cor-2026-06-02roche.com· Posted Sep 25, 2026· Starts Nov 30, 2026 ✓· 31% of score
Roche's release says "The FDA is expected to make a decision on the approval by 30 November 2026", the PDUFA goal date set under Priority Review.
- [2]70%Breast Cancer Breakthroughs: ASCO 2026 - Trials Testing Giredestrant (lidERA, persevERA and evERA) (Susan G. Komen)youtube.com· Published Sep 3, 2026· 29% of score
Komen Scholar Dr. Mariana Chavez MacGregor on the giredestrant trials presented at ASCO 2026.[1]
- [3]80%FDA Grants Priority Review to Giredestrant in ER+/HER2- Early Breast Cancer (CancerNetwork)cancernetwork.com· Published Jun 3, 2026· 20% of score
Reports the PDUFA date of November 30, 2026 and the lidERA data behind the application.[1]
- [4]90%FDA Accepts New Drug Application for Genentech's Giredestrant in ER-Positive Early-Stage Breast Cancergene.com· Published Jun 1, 2026· 20% of score
Genentech's US release: "The FDA has set a Prescription Drug User Fee Act date of November 30, 2026"; Priority Review; calls giredestrant "the first significant advance in adjuvant endocrine therapy in over 20 years".[1]
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