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news.The US Food and Drug Administration (FDA) has accepted priority review of the new drug application (NDA) for Roche’s investigational oral selective oestrogen receptor degrader (SERD), giredestrant, for breast cancer.
The filing acceptance is based on Phase III data from the lidERA Breast Cancer study. Credit: Arif biswas / Shutterstock.com.
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The application seeks approval of giredestrant as an adjuvant treatment for adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I to III breast cancer.
A decision from the FDA is anticipated by 30 November 2026.
Roche chief medical officer and global product development head Levi Garraway said: “Giredestrant represents the first major endocrine therapy advance in early-stage ER-positive breast cancer in decades, where the chance for cure is highest.
“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.”
The filing acceptance is based on Phase III data from the lidERA Breast Cancer study. The results showed adjuvant giredestrant reduced the risk of invasive disease recurrence or death by 30% compared to standard-of-care endocrine therapy.
After three years, 92.4% of patients in the giredestrant group remained free of invasive disease compared to 89.6% in the control arm.
The benefit in invasive disease-free survival (iDFS) was consistent across clinically relevant subgroups. Overall survival data are currently immature, but a positive trend was observed.
Treatment discontinuation due to adverse events occurred in 5.3% of giredestrant patients and 8.2% of those on standard therapy.
Ongoing and additional analyses from the giredestrant programme, including recent data presentations at the 2026 American Society of Clinical Oncology Congress, continue to support the clinical profile of giredestrant across ER-positive early-stage and advanced breast cancer.
The FDA has also accepted an NDA for giredestrant combined with everolimus in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected in December 2026.
The Phase III, randomised, open-label, multicentre lidERA study enrolled more than 4,100 patients with medium-risk or high-risk stage I-III ER-positive, HER2-negative breast cancer.
The primary endpoint was invasive disease-free survival. Key secondary endpoints included overall survival, disease-free survival, and safety.
In April 2026, Roche signed a new collaboration agreement with C4 Therapeutics to jointly advance research in the field of degrader-antibody conjugates, aiming to introduce a new therapeutic modality for cancer.
