The PARP inhibitor had previously been approved to treat active ovarian cancer in women who received at least 2 lines of chemotherapy.
FDA on Friday approved rucaparib, sold by Clovis Oncology as Rubraca, for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. This new indication comes after FDA previously approved the PARP inhibitor to treat active disease in patients with germline/somatic BRCA mutations who have received at least 2 lines of chemotherapy, based on results of the ARIEL 3 trial.
Rucaparib was approved under FDA’s expedited review process, and use of the therapy for maintenance in ovarian cancer was added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in February. The NCCN designated Rubraca as a category 2A treatment. Biomarker testing is not required for patients to receive rucaparib in the maintenance indication, according to a statement from Clovis Oncology.
“Rubraca provided statistically-significant improvement in PFS [progression-free surival] versus placebo to all patients, regardless of BRCA mutation status,” said Robert L. Coleman, MD, a principal investigator of the ARIEL 3 trial who is a professor in the Department of Gynecologic Oncology and Reproductive Medicine at University of Texas MD Anderson Cancer Center in Houston.
“Both the efficacy and safety results from the ARIEL3 study reinforce the important role of Rubraca in the treatment of recurrent ovarian cancer and expands the treatment options for patients and physicians battling this disease.”
ARIEL 3, which involved 564 patients, successfully met its primary and key secondary endpoints. Patients assigned rucaparib had improved PFS compared with patients assigned placebo (median, 10.8 months vs. 5.4 months; hazard ratio, 0.36; 95% CI, 0.3-0.45).