FDA Grants Accelerated Approval to Rubraca for BRCA-positive Advanced Ovarian Cancer

FDA Grants Accelerated Approval to Rubraca for BRCA-positive Advanced Ovarian Cancer
The U.S. Food and Drug Administration (FDA) granted accelerated approval to Clovis Oncology’s drug candidate Rubraca (rucaparib) to treat women with BRCA-positive advanced ovarian cancer, who have been treated with two or more chemotherapies. “Today’s approval is another example of the trend we are seeing in developing targeted agents to treat cancers caused by specific mutations in a patient’s genes,”  Richard Pazdur, MD, 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, said in a press release. “Women with these gene abnormalities who have tried at least two chemotherapy treatments for their ovarian cancer now have an additional treatment option.” According to the National Cancer Institute, about 15 percent to 20 percent of patients with ovarian cancer have a BRCA gene mutation. Rubraca is a poly ADP-ribose polymerase (PARP) inhibitor with potential as an anti-cancer agent, that targets the DNA repair enzyme poly-ADP ribose polymerase-1 (PARP-1). BRCA genes are required for normal DNA repair mechanisms, and as such, by blocking this enzyme, the DNA inside cancerous cells with damaged BRCA genes is less likely to be repaired, causing the cells to die and, possibly, slowing tumor growth. BRCA mutations are considered particularly deleterious. The FDA also approved the
Subscribe or to access all post and page content.