Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276), a China-based pharmaceutical company, has announced that its indication approval filing for fluzoparib—a poly (ADP-ribose) polymerase (PARP) inhibitor—has been awarded breakthrough therapy designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation applies to fluzoparib, both as a monotherapy and in combination with the small-molecule targeted cancer therapy apatinib, for the treatment of HER2-negative breast cancer with gBRCA mutations.
Fluzoparib specifically 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. Developed entirely in-house, the drug later secured approval in June 2021 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.
Apatinib, a VEGFR-2 tyrosine kinase inhibitor (TKI), is designed to impede tumor angiogenesis. It was initially approved in 2014 for advanced gastric cancer/adenocarcinoma at the gastroesophageal junction (GC/GEJ) that has progressed or relapsed after at least two systemic chemotherapies. The drug has since expanded its indications, receiving approval in January 2021 for advanced hepatocellular carcinoma in patients who are unresponsive to or intolerant of first-line or subsequent systemic therapies, and for first-line treatment of HCC in combination with camrelizumab in January of last year.- Flcube.com
