Second indication for Rubraca approved in Europe

American PARP inhibitor specialist Clovis Oncology (Nasdaq: CLVS) says that the European Commission has approved the use of its Rubraca(rucaparib) for a second indication, as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

This expands rucaparib’s indication beyond its initial marketing authorization in Europe granted in May 2018 and with this label expansion, rucaparib is now available to patients regardless of their BRCA mutation status. Rucaparib was the first PARP inhibitor licensed for an ovarian cancer treatment indication in the European Union and is now the first to be available for both treatment and maintenance treatment among eligible patients.

The EC authorization is based on data from the Phase III ARIEL3 clinical trial, which found that rucaparib significantly improved progression-free survival in all ovarian cancer patient populations studied.