Clovis Oncology Announces European Commission Authorization of Rubraca (rucaparib) for Women with Recurrent Ovarian Cancer

Clovis Oncology (NASDAQ: CLVS) today announced that the European Commission (EC) has authorized Rubraca (rucaparib) as monotherapy treatment of adult patients with platinum-sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy. Certain confirmatory post-marketing commitments are required as part of this conditional authorization.

As quoted in the press release:

For the full European approved prescribing information, please refer to the Rubraca (rucaparib) Summary of Product Characteristics on the European Medicines Agency website.

“Rucaparib provides a unique opportunity within Europe for women with BRCA mutated ovarian cancer, for whom platinum chemotherapy isn’t an option, to receive an oral non-chemotherapy treatment,” said Dr. Rebecca Kristeleit, Clinical Senior Lecturer and Consultant Medical Oncologist, University College London, U.K. “In this group of patients with limited treatment options, rucaparib provides a much-needed oral targeted therapy for these women.”

Click here to read the full press release.