Roche’s Breast Cancer Drug Giredestrant Gets FDA Priority Review

On June 2, 2026, Roche (OTC: RHHBY) announced the U.S. Food and Drug Administration accepted its New Drug Application for giredestrant, an oral selective estrogen receptor degrader, granting priority review. The expedited pathway shortens the regulatory timeline to six months, with a decision expected by year-end. Giredestrant is designed for patients with ER-positive, HER2-negative breast cancer, the most common subtype. The filing is backed by pivotal trial results demonstrating its efficacy. Priority review underscores the unmet need for novel therapies in this population. If approved, the drug would offer a convenient oral alternative to existing injectable options. Roche continues to strengthen its oncology portfolio with this potential first-in-class treatment.