FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

European Commission OK’s Clovis Oncology’s Ovarian Cancer Drug

Feb. 4, 2019

The European Commission granted an expanded approval for Clovis Oncology’s Rubraca (rucaparib), approving the medicine as a maintenance treatment for women suffering from relapsed ovarian cancer.

Rubraca may now be used as a monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who respond partially or completely to platinum-based chemo.

The EC authorization was based on data from a phase III clinical trial that found the medicine improved progression-free survival for all ovarian cancer populations studied.

The drug received its initial marketing authorization in Europe in May 2018. With the label expansion granted by the EC, the drug is now available to patients regardless of their BRCA mutation status.

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