FDA grants accelerated approval to Rubraca
Rubraca treats women who have advanced ovarian cancer that have previously received two or more chemotherapy treatments, as well as those who have tumors with a specific gene mutation known as deleterious BRCA -- which has been identified by a companion diagnostic test approved by the FDA.
"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," FDA Center for Drug Evaluation and Research Director of the Office of Hematology and Oncolgoy Products Dr. Richard Pazdur said. "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, approximately 22,280 women will contract ovarian cancer this year, 14,240 of whom will die from the disease. The BRCA gene mutation will show up in approximately 15-20 percent of these patients.
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