The U.S. Food and Drug Administration has set a Dec. 18 decision date on Roche’s giredestrant for ER-positive, HER2-negative breast cancer, based on a Phase 3 dataset that showed progression‑free survival benefits versus older hormone therapies. Roche characterized giredestrant as a potential new backbone oral SERD and is pursuing combination studies across its oncology portfolio. Analysts note the class is crowded—Menarini’s Orserdu and Lilly’s Inluriyo are already on the market—and commercial uptake will depend on broader benefit signals and positioning in earlier disease settings. Roche emphasized giredestrant’s activity in the evERA trial and flagged ongoing adjuvant and combination programs. The FDA decision will influence competitive dynamics in endocrine therapy for breast cancer and determine how payers and oncologists incorporate another oral SERD into treatment algorithms.