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Clovis' Rubraca approved in Europe for ovarian cancer

May 29, 2018 7:40 PM UTC

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.

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 Extra, April 6)...