Clovis Oncology submits applications for Rubraca label expansion in the US and European Union as first-line maintenance treatment in women with advanced ovarian cancer

Clovis Oncology

13 September 2022 - Submissions based on data from the Phase 3 ATHENA trial evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) presented at ASCO 2022.

Clovis Oncology today announced that it has submitted a supplemental new drug application with the US FDA and a Type II variation with the EMA for approval of Rubraca (rucaparib) as first-line maintenance treatment for women with advanced ovarian cancer regardless of biomarker status who have responded to first-line platinum-based chemotherapy.

Read Clovis Oncology press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , Europe , US , Dossier