FDA Accepts New Drug Application for Genentech's Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer

Core Viewpoint - Genentech, a member of the Roche Group, has received FDA acceptance for its New Drug Application for giredestrant, an investigational oral therapy for specific breast cancer patients [1] Group 1: Drug Development - The New Drug Application is for giredestrant, which is intended to be used in combination with everolimus [1] - The target patient population includes adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer [1]