Dec 19, 2016

Clovis Oncology has got the approval from U.S. FDA for its PARP inhibitor rucaparib for treating women with advanced ovarian cancer, who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA). The brand name of the drug is Rubraca.

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, said: “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. 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, 22,280 women have been diagnosed with ovarian cancer in 2016 and an estimated 14,240 have died of this disease. Nearly 15 to 20 percent of patients with ovarian cancer have a BRCA gene mutation.


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