Hengrui started fluzopali or combined with apatinib in the treatment of advanced ovarian cancer stage III
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Last Update: 2020-02-19
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Source: Internet
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Author: User
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In vernacular On February 18, Hengrui pharmaceutical registered to launch a phase III clinical study of fluzopali or fluzopali combined with apatinib mesylate compared with placebo in the maintenance treatment of advanced ovarian cancer after first-line platinum containing chemotherapy This randomized, double-blind, parallel controlled phase III clinical trial is scheduled for 680 patients with advanced ovarian cancer The first phase is to evaluate the safety of fluzopali combined with apatinib in platinum sensitive recurrent ovarian cancer The second phase is to evaluate the efficacy of fzopali in the maintenance treatment of advanced ovarian cancer with BRCA1 / 2 mutation after first-line platinum chemotherapy compared with placebo, and to evaluate the efficacy of fzopali combined with apatinib mesylate in the maintenance treatment of advanced ovarian cancer after first-line platinum chemotherapy compared with placebo The primary end point of the study was the type, incidence, classification (based on nci-ctcae V5.0 standard) and severity of the adverse events related to the investigational drug at or above the disease-free progression survival (PFS) and grade 3 evaluated by bIRC based on the RECIST v1.1 standard Fluzopali is a PARP inhibitor, which can specifically kill BRCA mutant tumor cells Fluzopali capsule has been included in the priority review varieties by the drug review center of the State Food and drug administration, and is intended to be used for the treatment of recurrent ovarian cancer with BRCA1 / 2 pathogenic or suspected pathogenic mutations that have undergone previous second-line or more chemotherapy At present, there are similar products abroad, olapali, rubrca, nirapali and talzenna, which have been approved for sale in the United States Olapali was approved for sale in China in August 2018, with the commodity name of Lipitor In December 2019, tolaparil of zaiding medicine was approved for marketing in China It is used for the maintenance treatment of platinum sensitive recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer in adult patients after complete or partial remission of chemotherapy with platinum Pamiparib (bgb-290) of Baiji Shenzhou and hwh-340 of humanwell are in clinical trial stage.
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