Giredestrant - (lidERA)

02 June 2026: Roche (SIX: RO, ROP; OTCQX: RHHBY) said the US FDA accepted its New Drug Application under Priority Review for giredestrant, an investigational oral selective estrogen receptor degrader (SERD), as adjuvant treatment for adults with ER-positive, HER2-negative stage I–III breast cancer. The FDA set a PDUFA action date of 30 November 2026.

The filing is based on the Phase III lidERA Breast Cancer trial (NCT04961996; >4,100 patients), where giredestrant significantly improved invasive disease-free survival (iDFS), reducing risk of invasive disease recurrence or death by 30% vs standard-of-care endocrine therapy (HR 0.70; 95% CI 0.57–0.87; p=0.0014). At three years, iDFS was 92.4% with giredestrant vs 89.6% with standard therapy; benefit was consistent across subgroups. Overall survival data were immature but showed a positive trend; follow-up continues. Discontinuation was 5.3% vs 8.2%; adverse events were described as manageable.

Roche also noted a separate FDA NDA acceptance for giredestrant + everolimus in ESR1-mutated, ER-positive advanced breast cancer (evERA), with a decision expected in December 2026. Additional analyses from the giredestrant program were presented at the 2026 ASCO Congress.