Rubraca™ Is Granted Accelerated Approval for Advanced Ovarian Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Rubraca™ (rucaparib) 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.

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.

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.

Rubraca was studied in 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 FoundationFocus™ 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.”

Reference: U.S. Food and Drug Administration. (2016.) FDA grants accelerated approval to new treatment for advanced ovarian cancer. [Press release.] Can be retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm533873.htm

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