FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer
Friday, February 20, 2026
Roche has announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) for giredestrant. The investigational oral therapy is being reviewed in combination with everolimus for the treatment of adult patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated locally advanced or metastatic breast cancer. The application covers patients whose disease has returned or progressed after previous endocrine-based treatment.
A regulatory decision is expected by 18 December 2026. If approved, giredestrant in combination with everolimus could become the first oral selective oestrogen receptor degrader (SERD) combination available for patients previously treated with CDK4/6 inhibitors.
The NDA is supported by results from the phase III evERA Breast Cancer study. The trial showed that giredestrant plus everolimus reduced the risk of disease progression or death by 44% in the intention-to-treat (ITT) population and by 62% in patients with ESR1 mutations, compared with standard endocrine therapy plus everolimus.
In patients with ESR1 mutations, median progression-free survival (PFS) was 9.99 months with the giredestrant combination, compared with 5.45 months in the comparator arm. In the overall ITT population, median PFS was 8.77 months versus 5.49 months, respectively.
Overall survival data remain immature, although a positive trend has been observed in both the ITT and ESR1-mutated groups. Follow-up for overall survival will continue in future analyses. The safety profile of the combination was consistent with the known effects of the individual medicines. Adverse events were manageable, and no unexpected safety issues were reported.
Data from the evERA study are also being submitted to regulatory authorities in other regions.
ER-positive breast cancer represents around 70% of all breast cancer cases. Resistance to endocrine treatment, particularly after CDK4/6 inhibitor therapy, is linked to a higher risk of disease progression and poorer outcomes. Oral combination approaches such as giredestrant plus everolimus aim to target different signalling pathways while reducing treatment burden, as injections are not required.
The evERA trial marks the first positive phase III outcome for giredestrant in advanced disease. This was followed by positive results from the lidERA Breast Cancer study in the early-stage setting. Earlier data from the coopERA trial in the neoadjuvant setting showed that giredestrant reduced tumour cell proliferation more effectively than an aromatase inhibitor.
Roche plans to submit phase III data from the lidERA study to global health authorities, including the FDA, in the coming weeks. Results from the persevERA study in first-line ER-positive breast cancer are expected in the first half of the year, which may further support the role of giredestrant across different stages of the disease.
The company’s clinical development programme for giredestrant covers multiple treatment settings and lines of therapy, reflecting its focus on expanding options for patients with ER-positive breast cancer.
Source: globenewswire.com
