9 October 2017 - Company plans to file marketing authorisation application in Europe in early 2018 for maintenance treatment indication.
Clovis Oncology announced today that the company has submitted a supplemental new drug application to the U.S. FDA for rucaparib as maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
The submission is based on data from the phase 3 ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied.
Read Clovis Oncology press release