EMA has started a review of the cancer medicine Rubraca (rucaparib camsylate) when it is used to treat cancer of the ovary, fallopian tubes or peritoneum with a BRCA mutation in patients whose cancer has come back after platinum-based chemotherapy and who can no longer have these medicines.

The review follows preliminary results indicating that overall survival was shorter in these patients than in those receiving chemotherapy. These results come from the ongoing ARIEL4 study  comparing Rubraca with chemotherapy in patients with high-grade cancer of the ovary, fallopian tubes or peritoneum with a BRCA mutation whose cancer has come back after chemotherapy.

While the review is ongoing, EMA is recommending that doctors do not start treatment in new patients whose cancer has a BRCA mutation and has come back after at least two platinum-based chemotherapies and who cannot have further platinum-based therapy (third-line treatment). This recommendation does not affect the use of Rubraca as maintenance treatment following chemotherapy. Healthcare professionals will be informed in writing of the updated treatment recommendations.

EMA will now assess all available information on the use of Rubraca as third-line treatment and recommend whether Rubraca’s marketing authorisation in the EU should be maintained or varied.