Clovis Oncology Inc. submitted an application with the European Medicines Agency, seeking approval to expand the indication of its drug Rubraca.
Specifically, the company wants its drug to be used as a so-called maintenance therapy to improve the effectiveness of chemotherapy in adult patients with certain types of ovarian cancer.
The company expects an opinion from the regulator by the end of 2018.
The medicine is approved in Europe as a treatment for BRCA mutated epithelial ovarian, fallopian tube or primary peritoneal cancer patients who have been treated at least twice with chemotherapy and are unable to tolerate it any further.
It is also approved in the U.S. to keep ovarian cancer from recurring in certain patients after chemotherapy.
