China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that the National Medical Products Administration (NMPA) has accepted a new indication filing for its poly (ADP-ribose) polymerase (PARP) inhibitor, fluzoparib. The filing seeks to expand the use of fluzoparib as a maintenance therapy for patients with advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial remission through first-line platinum-containing chemotherapy.
Phase III Study Supports Fluzoparib’s Efficacy and Safety
The filing is supported by a randomized, double-blind, controlled, multi-center Phase III study. Results indicate that fluzoparib as a maintenance therapy significantly prolongs the progression-free survival of patients with advanced ovarian cancer, reduces the risk of disease progression or death, and provides benefits irrespective of BRCA1/2 status. Preliminary survival follow-up data also suggest a positive trend in prolonging overall survival (OS) for the experimental group, along with a good tolerability and safety profile.
Fluzoparib’s Targeted Action and Previous Approvals
Fluzoparib targets BRCA mutant tumor cells and received conditional market approval in China in December 2020 for use as a second-line treatment for recurrent ovarian cancer with BRCA1/2 mutations. The in-house developed drug further expanded its indications in June 2021, obtaining approval as a maintenance treatment for platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer following platinum-containing chemotherapy with complete or partial remission.-Fineline Info & Tech
