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

Core Insights - Roche's New Drug Application for giredestrant has been accepted by the U.S. FDA for treating advanced ER-positive breast cancer, with a decision expected by December 18, 2026 [1][7] - Giredestrant in combination with everolimus has shown significant efficacy in delaying disease progression, with a 44% reduction in risk in the intention-to-treat population and 62% in the ESR1-mutated population [2][7] Company Developments - The acceptance of the filing is based on positive results from the phase III evERA Breast Cancer study, which demonstrated improved progression-free survival (PFS) compared to standard therapies [2][9] - Roche plans to submit additional data from the giredestrant clinical program to other global health authorities, indicating a broad strategy for regulatory approval [4][6] Clinical Study Results - In the ESR1-mutated population, median PFS was 9.99 months for giredestrant plus everolimus versus 5.45 months for the comparator, while in the ITT population, it was 8.77 months versus 5.49 months [2][10] - Overall survival data showed a positive trend, with HR of 0.69 in the ITT population and 0.62 in the ESR1-mutated population, although data were still immature at the time of analysis [3][10] Market Context - ER-positive breast cancer represents approximately 70% of breast cancer cases, and there is a significant need for effective treatments due to resistance to existing endocrine therapies [5][13] - Giredestrant's oral formulation aims to provide a less invasive treatment option, potentially improving patient adherence and quality of life [5][11] Future Outlook - Roche's extensive clinical development program for giredestrant includes multiple phase III trials across various treatment settings, reinforcing its commitment to addressing the needs of patients with ER-positive breast cancer [12][15] - Upcoming data from the lidERA trial and the persevERA readout are expected to further support giredestrant's role in the treatment landscape for ER-positive breast cancer [6][12]