FDA approves Clovis' Rubraca in maintenance setting

FDA approved an sNDA from Clovis Oncology Inc. (NASDAQ:CLVS) for Rubraca rucaparib as maintenance treatment for women with recurrent, platinum-sensitive ovarian cancer, regardless of BRCA mutation status. The agency also converted to regular approval its accelerated approval of Rubraca to treat germline or somatic BRCA-mutant advanced ovarian cancer in a third-line setting.

Clovis said biomarker testing is not required for patients in the maintenance setting...