Fuzuloparib: First Approval

Abstract

Fuzuloparib (AiRuiYi®, 艾瑞颐; formerly fluzoparib) is a small molecule, orally active PARP inhibitor being developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (formerly Jiangsu Hengrui Medicine Co., Ltd.) for the treatment of solid cancers. Fuzuloparib has been approved in China for the treatment of ovarian cancer (including fallopian tube cancer or primary peritoneal cancer), and phase II and III trials are investigating fuzuloparib for the treatment of other solid cancers, including cancers of the pancreas, breast, prostate and lungs. This article summarizes the milestones in the development of fuzuloparib leading to this first approval for the treatment of platinum-sensitive recurrent ovarian cancer, fallopian tube cancer or primary peritoneal cancer in patients with germline BRCA mutation who have undergone second-line or above chemotherapy.