Clovis' Rubraca approved in Europe for ovarian cancer

Clovis Oncology Inc. (NASDAQ:CLVS) said the European Commission granted conditional approval to an MAA for Rubraca rucaparib to treat ovarian cancer. The drug is approved to treat platinum-sensitive, relapsed or progressive ovarian cancer in the third-line setting in patients with germline or somatic BRCA-mutations. The company said Rubraca is the first PARP inhibitor approved in Europe to treat ovarian cancer.

In April, FDA approved an sNDA for Clovis' Rubraca rucaparib as maintenance treatment for women with recurrent, platinum-sensitive ovarian cancer, regardless of BRCA mutation status. FDA 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 (see BioCentury, April 13)...