FDA reviewing Rubraca for ovarian cancer maintenance

FDA accepted and granted Priority Review to an sNDA from Clovis Oncology Inc. (NASDAQ:CLVS) for Rubraca rucaparib 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 jumped 47% to $87.88 after reporting that Rubraca met the primary endpoint of improving progression-free survival (PFS) vs. placebo in ARIEL 3 (see BioCentury Extra, June 19)...