FDA reviewing Clovis' Rubraca for ovarian cancer maintenance

FDA accepted and granted Priority Review to an sNDA from Clovis Oncology Inc. (NASDAQ:CLVS) for Rubraca rucaparib (CO-338) as maintenance therapy for women with recurrent, platinum-sensitive ovarian cancer, regardless of BRCA mutation status. The PDUFA date is April 6.

The submission was based on data from the Phase III ARIEL3 trial. In June, Clovis reported Rubraca met the primary endpoint of improving progression-free survival (PFS) vs. placebo in ARIEL 3 (see BioCentury, June 23)...