Giredestrant + everolimus

Note: Roche's official media release dated 20 February 2026 (fetched and read in full 2026-08-02) carries the headline bullet 'The FDA has set a Prescription Drug User Fee Act date of 18 December' and, in the body, 'The FDA is expected to make a decision on the approval by 18 December 2026.' Same release: 'the United States (U.S.) Food and Drug Administration (FDA) has accepted the company's New Drug Application for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adult patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen.' Basis: Phase III evERA Breast Cancer (44% and 62% reduction in risk of progression or death in ITT and ESR1-mutated populations respectively vs standard-of-care endocrine therapy plus everolimus). Genentech's 2026-06-01 release re-states the timing for this application as a decision 'expected in December 2026'. DO NOT MERGE with our existing giredestrant entry at 2026-11-30 — that is the SEPARATE adjuvant early-breast-cancer NDA reviewed under Priority Review; our own note on that record already flags this Dec 18 combination NDA as distinct. Review designation for this combination NDA is not stated by Roche, hence designations left empty. Roche is not an SEC filer, so this entry cannot be corroborated via EDGAR; it was surfaced by aggregator cross-check and then verified only against roche.com.