Roche (RHHBY,RO.SW,ROG.SW) announced that the FDA has accepted the company'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. 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%.
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