The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for accelerated approval of rucaparib and granted priority review status to the application for the treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated cancers. Rucaparib was granted Breakthrough Therapy Designation by the FDA in April 2015.
About Ovarian Cancer
According to the American Cancer Society, more than 22,000 women will be diagnosed with ovarian cancer in the U.S. during 2016. There are often no clearly identifiable initial symptoms, and in an estimated 80 to 85% of ovarian cancer cases, the cancer has spread to other parts of the body before a person is diagnosed and can be treated. Ovarian cancer ranks fifth in cancer deaths and causes more deaths than any other cancer of the female reproductive system. One in four women with ovarian cancer have a germline or somatic BRCA mutation, and new treatment options are needed to treat unique patient populations.
Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed for advanced ovarian cancer.
Specifically, rucaparib is being developed as monotherapy treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated tumors inclusive of both germline and somatic BRCA mutations (as detected by an FDA-approved test) who have been treated with two or more chemotherapies.
About the Submission: Efficacy
Rucaparib was assessed in 106 patients from two multicenter, single-arm, open-label clinical trials in patients with advanced BRCA-mutant ovarian cancer who had progressed after two or more prior chemotherapies. The average age of evaluated patients was 59 years and they had been previously treated with an average of 3 prior chemotherapy regimens.
Overall 60% of platinum sensitive patients, and 54% of all patients responded to treatment. Treatment with Rucaparib was generally well tolerated and the average duration of response was 9.2 months.
Additional clinical trials are ongoing with the ARIEL (Assessment of Rucaparib in Ovarian Cancer Trial) program, a novel, integrated translational-clinical program designed to accurately and prospectively identify ovarian cancer patients with tumor genotypes associated with benefit from rucaparib therapy.
Reference: Clovis Oncology. (2016.) FDA Accepts Clovis Oncology’s New Drug Application for Rucaparib for Priority Review for the Treatment of Advanced Mutant BRCA Ovarian Cancer. [Press release.] Can be retrieved from http://ir.clovisoncology.com/phoenix.zhtml?c=247187&p=irol-newsArticle&ID=2196955