FDA OKs Rucaparib as Maintenance Treatment of Recurrent Ovarian Cancer

Rucaparib demonstrated statistically-significant improvement in progression-free survival for patients in the maintenance treatment setting.

Officials with the FDA have approved rucaparib (Rubraca) for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy, regardless of BRCA mutation status, according to a press release. No biomarker testing is required for the treatment to be prescribed in this indication.

Rucaparib is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation associated with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 2 or more chemotherapies, and selected for therapy based on FDA-approved companion diagnostic for rucaparib.

The approval is based on positive data from the phase 3 ARIEL3 clinical trial that evaluated rucaparib in the ovarian cancer maintenance treatment-setting among 3 populations: BRCA mutant, HRD positive inclusive of BRCA mutant, and all patients treated in ARIEL3.

In the trial, which included 561 patients, rucaparib provided statistically significant improvement in progression-free survival compared with placebo in all patients, regardless of BRCA mutation status. Clovis announced the results in June 2017 and additional data from the trial were presented at the 2017 European Society for Medical Oncology Annual Conference in Madrid, Spain.

“The FDA approval of Rubraca in the maintenance treatment setting is an important milestone for physicians and their patients with recurrent ovarian cancer because it offers them greater flexibility to use this novel PARP inhibitor, which has demonstrated significant clinical efficacy and has been well received in practice,” professor Jonathan Ledermann, MD, principal investigator for the ARIEL3 study, said in the press release.

Based on data from the trial, the safety of rucaparib’s 600 mg twice daily as monotherapy for maintenance treatment was consistent with the previous studies that evaluated rucaparib. The most common adverse reaction was anemia and the most common lab abnormality was decreased hemoglobin.


Rubraca (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer [news release]. Clovis Oncology’s website. http://clovisoncology.com/files/rubraca-maintenance-treatment-approval-release.pdf. Accessed April 6, 2018.