News|Articles|June 2, 2026

FDA Accepts NDA for Giredestrant in ER-Positive Early-Stage Breast Cancer

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Key Takeaways

Priority review was granted for adjuvant giredestrant in ER-positive, HER2-negative stage I–III disease, positioning an oral SERD for potential use in the curative-intent setting.
lidERA demonstrated a 30% reduction in invasive disease recurrence or death and improved 3-year iDFS (92.4% vs 89.6%), with consistency across clinically relevant subgroups.
Overall survival analyses were immature at the reported cut, although a favorable trend was observed, supporting the benefit-risk assessment for earlier-stage deployment.
Tolerability appeared favorable with lower treatment discontinuation (5.3% vs 8.2%) and manageable adverse events aligned with the established safety profile.
A separate U.S. NDA for giredestrant plus everolimus in ESR1-mutated, ER-positive advanced disease is also under FDA review, with a December 2026 decision expected.

FDA has accepted Roche's NDA for giredestrant under Priority Review, moving the investigational oral SERD closer to potential approval .

FDA accepted Roche's New Drug Application (NDA) under Priority Review for giredestrant.

The treatment is an investigational oral selective estrogen receptor degrader (SERD), and serves as an adjuvant treatment for adults with estrogen receptor (ER)-positive, HER2-negative stage I, II, and III breast cancer.¹ FDA’s decision on the treatment’s approval is expected by November 30, 2026.

The filing acceptance marks a significant step for a therapy Roche believes could become a new standard of care in early-stage ER-positive breast cancer, a setting where current endocrine therapies leave up to a third of patients eventually experiencing recurrence.¹

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What data supported the FDA's acceptance?

Results from the Phase III lidERA Breast Cancer study, in which adjuvant giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy,²support the NDA. At three years, 92.4% of patients in the giredestrant arm were alive and free of invasive disease, compared with 89.6% in the standard-of-care arm.The benefit was consistent across all clinically relevant subgroups. Overall survival data were immature at the time of analysis, though a positive trend was observed.²

"Giredestrant represents the first major endocrine therapy advance in early-stage ER-positive breast cancer in decades, where the chance for cure is highest," said Levi Garraway, MD, PhD, Roche's chief medical officer and head of global product development. "The FDA's filing acceptance brings us closer to delivering a new standard-of-care with the potential to fundamentally change the treatment paradigm for people with early-stage disease."

In the trial, Giredestrant was well tolerated with a treatment discontinuation rate of 5.3% compared with 8.2% for standard-of-care endocrine therapy, along with adverse events remaining manageable and consistent with the drug's known safety profile.²

What is giredestrant?

Giredestrant is an investigational oral next-generation SERD and full estrogen receptor antagonist designed to block estrogen from binding to the receptor, triggering its breakdown and halting cancer cell growth.¹ It is currently being evaluated across five company-sponsored Phase III trials spanning multiple treatment settings and lines of therapy.

FDA’s NDA acceptance is not the only regulatory milestone for giredestrant in the U.S., as the agency also recently accepted a separate NDA for giredestrant in combination with everolimus for patients with ESR1-mutated, ER-positive advanced breast cancer, based on results from the evERA study, with a decision expected in December 2026.

Why is giredestrant’s approval important?

According to Roche, ER-positive breast cancer accounts for approximately 70% of all breast cancer diagnoses globally, with 2.3 million new cases of breast cancer reported each year.¹ The majority are diagnosed at early stage, yet current adjuvant endocrine therapies are hampered by tolerability issues, leading many patients to discontinue treatment, increasing their risk of recurrence and death. Giredestrant's efficacy and tolerability profile, if approved, has the potential to address both limitations in a disease setting where outcomes stand to benefit most from therapeutic advances.

Sources

FDA accepts New Drug Application for Roche’s giredestrant in ER-positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting Roche June 1, 2026 https://www.roche.com/media/releases/med-cor-2026-06-02
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer) National Library of Medicine May 22, 2026 https://clinicaltrials.gov/study/NCT04961996?term=lidera%20breast%20cancer&rank=1
FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer Roche February 19, 2026 https://www.roche.com/media/releases/med-cor-2026-02-20

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