FDA accepts New Drug Application for Roche's giredestrant in ESR1-mutated, ER-positive advanced breast cancer

Core Viewpoint - Roche's giredestrant, in combination with everolimus, has received FDA acceptance for a New Drug Application aimed at treating advanced ER-positive breast cancer, with a decision expected by December 18, 2026 [1][5]. Group 1: Clinical Efficacy - The phase III evERA Breast Cancer study demonstrated that giredestrant plus everolimus reduced the risk of disease progression or death by 44% in the intention-to-treat (ITT) population and by 62% in the ESR1-mutated population compared to standard-of-care therapy [2][5]. - In the ESR1-mutated population, the median progression-free survival (PFS) was 9.99 months for giredestrant compared to 5.45 months for the comparator arm, while in the ITT population, the median PFS was 8.77 months versus 5.49 months [2][5]. - Overall survival data showed a positive trend in both ITT (HR=0.69) and ESR1-mutated populations (HR=0.62), although data were immature at the time of analysis [2][5]. Group 2: Treatment Context - ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and resistance to endocrine therapies is a significant challenge, particularly after CDK4/6 inhibitor treatment [3][8]. - Giredestrant's oral combination therapy aims to address treatment resistance by targeting different signaling pathways, potentially improving patient quality of life by eliminating the need for injections [3][8]. Group 3: Future Developments - Roche plans to submit additional phase III data from the lidERA study for early-stage breast cancer to health authorities worldwide, including the FDA [3][6]. - The persevERA readout in first-line ER-positive breast cancer is anticipated in the first half of the year, which will further support giredestrant's role in treatment [3][6]. Group 4: Company Commitment - Roche has a comprehensive clinical development program for giredestrant, reflecting its commitment to providing innovative treatments for patients with ER-positive breast cancer across various settings [4][9].