by Dr. C.H. Weaver M.D. updated 9/2019
Rubraca® (rucaparib) has been approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Biomarker testing is not required for patients to be prescribed Rubraca in this maintenance treatment indication.
Rubraca® is an orally taken poly ADP-ribose polymerase (PARP) inhibitor that works by blocking PARP1, PARP2 and PARP3 enzymes involved in repairing damaged DNA. By blocking these enzymes, DNA inside the cancer cells with damaged BRCA genes may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth.
About the ARIEL3 Clinical Trial
The ARIEL3 clinical trail evaluating Rubraca enrolled 564 patients with high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer previously treated with at least two prior platinum-based chemotherapy treatment regimens, and achieved a complete or partial response to their most recent platinum-based regimen. There were no genomic selection criteria for this study. Half the patients were treated with Rubraca given as a maintenance treatment and their outcomes were compared to those not receiving maintenance.
The trial evaluated two prospectively defined molecular sub-groups of individuals:
- Tumor BRCA mutant (tBRCAmut) patients, inclusive of germline and somatic mutations of BRCA;
- HRD-positive patients, including BRCA-mutant patients and BRCA wild-type with high loss of heterozygosity, or LOH-high patients;
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Rubraca® demonstrated significant improvement for all 564 patients enrolled in the study. Rubraca® treated patients survived on average 13.7 months without cancer progression compared to 5.4 months for those not receiving Rubraca®.(1)
These and other data led to the U.S. Food and Drug Administration (FDA) granting accelerated approval to Rubraca™ for the treatment of women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a BRCA gene mutation.
BRCA genes are involved with repairing damaged DNA and normally work to prevent tumor development. However, mutations of these genes may lead to certain cancers, including ovarian cancers. Rubraca is a poly ADP-ribose polymerase (PARP) inhibitor that blocks an enzyme involved in repairing damaged DNA. By blocking this enzyme, DNA inside the cancerous cells with damaged BRCA genes may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth.
The FDA evaluated two, single-arm clinical trials involving 106 patients with BRCA gene mutations whose tumors progressed after two or more chemotherapy regimens. BRCA mutations were confirmed in 96 percent of patients by using FDA approved Foundation Focus™ CDxBRCA companion diagnostic. Fifty-four percent of the participants who received Rubraca in the trials experienced complete or partial shrinkage of their tumors lasting a median of 9.2 months.
Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and acting director of the FDA’s Oncology Center of Excellence says “Women with these gene abnormalities who have tried at least two chemotherapy treatments for their ovarian cancer now have an additional treatment option.”(3)
- Rubraca® (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer
- U.S. Food and Drug Administration. (2016.) FDA grants accelerated approval to new treatment for advanced ovarian cancer. [Press release.]