5 December 2017 - Priority review granted based on positive data from phase 3 ARIEL3 clinical trial in which rucaparib significantly improved PFS in all ovarian cancer patient populations studied.

Clovis Oncology announced today that the U.S. FDA has accepted the company’s supplemental new drug application for rucaparib and granted priority review status to the application with a Prescription Drug User Fee Act date of 6 April 2018. 

In October, Clovis completed its sNDA submission for rucaparib as maintenance treatment in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are platinum sensitive, and in a complete or partial response to platinum-based chemotherapy. Clovis is seeking approval for use of rucaparib for this indication regardless of a patient’s BRCA mutation status.

Read Clovis Oncology press release