Roche Announces FDA's Filing Acceptance Under Priority Review For Giredestrant

(RTTNews) - Roche (RHHBY, RO.SW, ROG.SW) announced the FDA has accepted the company's New Drug Application under Priority Review for giredestrant, an investigational oral selective oestrogen receptor degrader, as an adjuvant treatment for adults with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, stage I, II, and III breast cancer. The FDA is expected to make a decision on the approval by 30 November 2026.

The FDA recently accepted the NDA for giredestrant in combination with everolimus for those with ESR1-mutated, ER-positive advanced breast cancer based on the evERA results, with a decision expected in December 2026.

At last close, Roche shares were trading at 317.40 Swiss francs, down 3.61%.

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