April 9, 2018

Rubraca® Approved as Maintenance Treatment of Recurrent Ovarian Cancer

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CancerConnect News: 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.

About Rubraca®

Rubraca® is an oral taken poly ADP-ribose polymerase (PARP) inhibitor that works by blocking PARP1, PARP2 and PARP3 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.

About Ovarian Cancer

Each year in the U.S. roughly 22,000 women are diagnosed with ovarian cancer and more than 15,000 die of the disease. Approximately 15 to 20 percent of patients with ovarian cancer have a BRCA gene mutation.

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:

1) Tumor BRCA mutant (tBRCAmut) patients, inclusive of germline and somatic mutations of BRCA;

2) HRD-positive patients, including BRCA-mutant patients and BRCA wild-type with high loss of heterozygosity, or LOH-high patients;

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®.

Reference: http://markets.businessinsider.com/news/stocks/rubraca-rucaparib-approved-in-the-u-s-as-maintenance-treatment-of-recurrent-ovarian-cancer-1020701836

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Tags: cancer treatment, News, ovarian, Ovarian Cancer, poly ADP-ribose polymerase (PARP) inhibitor, recurrent, Rubraca, treatment, Uncategorized