fovinaciclib

Fovinaciclib is a novel, potent, oral selective cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor developed by Fosun Pharma and Avanc Pharmaceutical. It is primarily indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. By inhibiting CDK4 and CDK6, fovinaciclib prevents the phosphorylation of the retinoblastoma (Rb) protein, leading to cell cycle arrest in the G1 phase and inhibiting tumor cell proliferation. Clinical data from Phase 3 trials (NCT05438810, NCT05439499) have demonstrated significant improvements in progression-free survival when combined with endocrine therapies like fulvestrant or aromatase inhibitors. It is also being evaluated in neoadjuvant settings for HR-positive/HER2-positive early breast cancer in combination with endocrine therapy and dual HER2 blockade.