ERW316

ERW316 is an orally bioavailable, selective small molecule inhibitor of cyclin-dependent kinase 2 (CDK2) developed by Novartis. CDK2 is a key regulator of the cell cycle, specifically the transition from G1 to S phase. In many cancers, including hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, CDK2 activity is often upregulated, contributing to tumor progression and resistance to CDK4/6 inhibitors. By selectively inhibiting CDK2, ERW316 aims to arrest the cell cycle and overcome resistance to standard endocrine and CDK4/6 targeted therapies. It is currently being evaluated in Phase I/II clinical trials as a single agent and in combination with endocrine therapies like fulvestrant or letrozole for patients with advanced solid tumors and HR+/HER2- breast cancer.