Roche (SIX: RO, ROP; OTCQX: RHHBY) has submitted a New Drug Application (NDA) to the US FDA for giredestrant, an investigational oral selective estrogen receptor degrader (SERD), as adjuvant treatment for adults with estrogen receptor (ER)-positive, HER2-negative stage I, II, and III breast cancer. The FDA has accepted the filing under Priority Review, marking a significant regulatory milestone for an oral SERD in the adjuvant breast cancer setting.
The NDA, submitted under Priority Review, seeks approval for giredestrant as an adjuvant endocrine therapy in patients with ER-positive, HER2-negative early-stage breast cancer across stage I through III. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of 30 November 2026, the company said. Separately, Roche noted that the FDA has also accepted an NDA for giredestrant in combination with everolimus for ESR1-mutated ER-positive advanced breast cancer, with a decision expected in December 2026.
The filing is supported by data from the lidERA Breast Cancer study (NCT04961996), a Phase III, randomized, open-label, multicenter trial evaluating adjuvant giredestrant versus standard-of-care endocrine therapy in patients with medium- or high-risk stage I–III ER-positive, HER2-negative breast cancer. The trial enrolled more than 4,100 patients, with invasive disease-free survival (iDFS) as the primary endpoint.
Results demonstrated that giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy (hazard ratio 0.70; 95% confidence interval 0.57–0.87; p=0.0014). 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 iDFS benefit was reported as consistent across clinically relevant subgroups. Overall survival data were immature at the time of analysis, though a positive directional trend was observed. The treatment discontinuation rate was 5.3% with giredestrant versus 8.2% with standard-of-care endocrine therapy, suggesting a tolerability profile that may support adherence.