Update on EMA marketing review of rucaparib for advanced ovarian cancer with BRCA mutation- Clovis Oncology.

Clovis Oncology, Inc. announced an update to the ongoing regulatory review for the Marketing Authorization Application (MAA) for rucaparib tablets as monotherapy for the treatment of a limited population of advanced ovarian cancer patients with deleterious BRCA mutation (germline and/or somatic). The indication under consideration by the Committee for Medicinal Products for Human Use (CHMP) focuses on a subset of platinum-sensitive disease where there is particular unmet medical need. Following a Scientific Advisory Group (SAG) - Oncology last week and an oral explanation this week, the European Union�s (EU) European Medicines Agency (EMA) CHMP has communicated a positive trend vote for the rucaparib MAA and their intention to hold a final vote on the treatment indication at their March meeting (March 19-22, 2018).

The CHMP application for the treatment indication currently under review was submitted during the fourth quarter of 2016 and was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. Patients received rucaparib orally 600 mg twice daily as monotherapy until disease progression or unacceptable toxicity. Objective response rate (ORR) and duration of response (DOR) were assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The most common Grade 3/4 adverse event was anemia.