Breast cancer is the second leading cause of death for women worldwide. The
heterogeneity of this disease presents a big challenge in its therapeutic management …

Tumor biomarkers, the substances which are produced by tumors or the body's responses to
tumors during tumorigenesis and progression, have been demonstrated to possess critical …

Background Ribociclib has been shown to have a significant overall survival benefit in
patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 …

Hormone receptor (HR)‐positive and human epidermal growth factor receptor 2 (HER2)‐
negative breast cancer is defined by the presence of the estrogen receptor and/or the …

Abstract Cyclin-dependent kinase (CDK) 4/6 inhibition in combination with endocrine
therapy is the standard-of-care treatment for patients with advanced-stage hormone receptor …

Metastatic breast cancer (MBC) is an incurable disease, but survival improvements have
been reported with appropriate therapeutic strategies. 1-8 Systemic therapy is the standard …

Background In a previous analysis of this phase 3 trial, first-line ribociclib plus letrozole
resulted in significantly longer progression-free survival than letrozole alone among …

Abstract Cyclin-dependent kinase 4 (CDK4) and CDK6 are critical mediators of cellular
transition into S phase and are important for the initiation, growth and survival of many …

Background In advanced oestrogen receptor-positive, HER2-negative breast cancer,
acquired resistance to aromatase inhibitors frequently stems from ESR1-mutated subclones …

Abstract The United States Food and Drug Administration (US FDA) has always been a
forerunner in drug evaluation and supervision. Over the past 31 years, 1050 drugs …