Roche announced an FDA target action date of Dec. 18 for giredestrant, its investigational oral SERD for ER‑positive, HER2‑negative breast cancer, based on Phase 3 data showing progression‑free survival gains versus older hormone therapies. Roche also reported an internal leadership change: Mark Dawson will head Roche Pharma Research & Early Development starting May 1. The regulatory deadline places giredestrant in direct competition with other oral SERDs and could influence combination strategies in breast cancer. The R&D leadership appointment underscores Roche’s emphasis on oncology and epigenetics as it positions new molecules for late‑stage development.