BOULDER — The European Medicines Agency (EMA) has accepted for review Clovis Oncology’s (Nasdaq: CLVS) application seeking approval for expanded use of its drug, Rubraca, also known as rucaparib.
The application is for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers. An opinion by the overseeing advisory group is expected by the end of the year.
Rubraca has previously been approved in the EU for adult patients with platinum sensitive, relapsed or progressive BRCA-mutated ovarian, fallopian tube or primary peritoneal cancers who have been treated two or more times with platinum-based chemotherapy and who aren’t able to be treated with it anymore.
“We are very pleased to receive validation of the variation to the Rubraca marketing authorization by the EMA, which brings us a step forward in making rucaparib available to more women with recurrent ovarian cancer in Europe,” said Patrick J. Mahaffy, CEO and president of Boulder-based Clovis, in a prepared statement.