Clovis Oncology's Rubraca marketing application accepted by European Medicines Agency.
M2 EQUITYBITES-July 9, 2018-Clovis Oncology's Rubraca marketing application accepted by European Medicines Agency
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United States-based Clovis Oncology has had its marketing application to the European Medicines Agency (EMA) accepted for a new indication of Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer, it was reported on Friday.
The regulator has accepted the application for a type II variation to the marketing authorisation for the product including maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum based chemotherapy. The application was submitted based on the positive results of phase three ARIEL3 study, which evaluated rucaparib in the ovarian cancer maintenance treatment setting among three populations, including BRCA mutant (BRCAmut+), HRD positive inclusive of BRCAmut+ and all patients treated in the ARIEL3 trial.
The product is an oral and small molecule inhibitor of poly ADP-ribose polymerase 1 (PARP1), PARP2 and PARP3. According to the company, the ARIEL3 study reached its primary endpoints, extending investigator evaluated progression-free survival against placebo in all patients treated, regardless of BRCA status.
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