- FDA to decide on giredestrant approval by December 18, 2026.
- Phase III data shows giredestrant plus everolimus reduces disease progression risk by 44% in ITT and 62% in ESR1-mutated populations.
- Median progression-free survival was 9.99 months for ESR1-mutated and 8.77 months for ITT populations.
- Adverse events were manageable and consistent with known safety profiles.
FDA Review Timeline
The FDA has accepted the New Drug Application for giredestrant, an investigational oral therapy, in combination with everolimus for treating ER-positive, ESR1-mutated advanced breast cancer. A decision is expected by December 18, 2026.
Phase III Study Results
The acceptance is based on phase III evERA Breast Cancer study results, which showed that giredestrant plus everolimus reduced the risk of disease progression or death by 44% in the intention-to-treat (ITT) population and 62% in the ESR1-mutated population compared to standard-of-care endocrine therapy plus everolimus. Median progression-free survival was 9.99 months for the ESR1-mutated group and 8.77 months for the ITT group.
Safety and Adverse Events
Adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of the individual medicines. No unexpected safety findings were observed, including no photopsia.
Global Submissions and Future Plans
Data from the evERA study are being used to support filing submissions to other global health authorities. Roche plans to submit phase III lidERA data in early-stage breast cancer to health authorities worldwide, including the FDA. The persevERA readout in first-line ER-positive breast cancer is expected in the first half of this year, providing further evidence for giredestrant in the ER-positive breast cancer treatment paradigm.
