Posted by Michael Wonder on 29 May 2018
Clovis Oncology announces European Commission authorisation of Rubraca (rucaparib) for women with recurrent ovarian cancer
29 May 2018 - First PARP inhibitor licensed for ovarian treatment indication in the EU.
Clovis Oncology 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 authorisation.
The EC approval was based on data from two multi-center, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. All patients received Rubraca orally 600 mg twice daily as monotherapy. Treatment continued until disease progression or unacceptable toxicity. The primary efficacy outcome measure of both studies was objective response rate as assessed by the investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
