FDA Accepts Roche NDA for Giredestrant in ER+/HER2- Breast Cancer with ESR1 Mutations
The FDA has accepted Roche's new drug application for giredestrant in combination with everolimus for ER-positive, HER2-negative, ESR1-mutated breast cancer, with a decision expected by December 18, 2026.
The US Food and Drug Administration has accepted Roche's New Drug Application for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adult patients with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen. The FDA is expected to make a decision on the approval by 18 December 2026.
The filing acceptance is based on the phase III evERA Breast Cancer study results. Giredestrant is being developed by Roche subsidiary Genentech in combination with the mTOR inhibitor Afinitor (everolimus) for this patient population.
In the coming weeks, Roche will submit the giredestrant phase III lidERA data in early-stage breast cancer to health authorities worldwide, including the FDA.
At last close, shares of Roche were trading at 368.20 francs, down 0.30%.