Colorado, USA’s Clovis Oncology (Nasdaq: CLVS) says its application to extend the marketing authorization for Rubraca (rucaparib) in Europe, to include maintenance treatment for certain patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, has been accepted.
If approved, the application would see the drug’s label extended to cover patients who are in a complete or partial response to platinum based chemotherapy.
The submission is based on positive results from the Phase III ARIEL3 study, which evaluated rucaparib in the ovarian cancer maintenance treatment setting.
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