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, Inc. (CLVS)
Last clovis oncology, inc. earnings: 2/24 04:05 pm
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Source: Business Wire
Submissions based on data from the Phase 3 ATHENA trial evaluating Rubraca monotherapy versus placebo (ATHENA-MONO) presented at ASCO 2022The ATHENA-MONO trial met its primary endpoint, showing Rubraca monotherapy versus placebo improved progression-free survival (PFS) by investigator assessment in both populations in the primary efficacy analyses: HRD-positive and all patients randomized (ITT)Safety of Rubraca observed in ATHENA-MONO was consistent with both the current US and European labelsThe Company has submitted a supplemental New Drug Application with the FDA and a Type II variation with the EMA BOULDER, Colo.--(BUSINESS WIRE)--Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that it has submitted a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) and a Type II variation with the European Medicines Agency (EMA) for approval of Rubraca® (rucaparib) as first-line maintenance treatment for women with advanced ovarian cancer regardless
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