Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that the National Medical Products Administration (NMPA) has approved a new indication for its PARP inhibitor, fluzoparib. The drug is now approved for use as a maintenance therapy in patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial remission following first-line platinum-based chemotherapy.
This regulatory milestone follows the positive outcomes from the Phase III FZPL-III-302 (FZOCUS-1) study. The study demonstrated that fluzoparib significantly improved progression-free survival in patients with advanced ovarian cancer, reduced the risk of disease progression or death, and showed benefits across all BRCA1/2 status. Preliminary survival follow-up data also indicated a positive trend in overall survival (OS), along with a favorable tolerability and safety profile.
Originally granted conditional market approval in China in December 2020 for second-line treatment of recurrent ovarian cancer with BRCA1/2 mutations, fluzoparib has since expanded its label. In June 2021, it received approval as a maintenance treatment for platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer following platinum-based chemotherapy with complete or partial remission.- Flcube.com
