FDA Grants Priority Review to Roche's (RHHBY) Breast Cancer Drug Giredestrant

The U.S. Food and Drug Administration granted priority review to Roche Holding AG’s (RHHBY) new drug application for giredestrant, an oral selective estrogen receptor degrader (SERD), for the treatment of patients with estrogen receptor-positive, HER2-negative advanced breast cancer. The agency set a target action date of Dec. 2, 2026, shortening the review period to six months from the standard 10 months. Priority review is granted to therapies that, if approved, would offer significant improvements over existing treatments. Giredestrant aims to challenge established injectable SERDs and other oral competitors. Roche’s application is supported by data from the Phase III persevERA study, which demonstrated a statistically significant improvement in progression-free survival compared to standard endocrine therapy in the first-line metastatic setting. A potential approval would strengthen Roche’s oncology portfolio as it faces biosimilar competition to legacy drugs like Herceptin. Shares of Roche were little changed in early trading.