In December 2016, the FDA approved Rubraca (rucaparib), a new oral PARP inhibitor, for the treatment of advanced ovarian cancer with a BRCA mutation (alteration) in patients who had received at least 2 chemotherapies.
“Recurrent ovarian cancer remains one of the most difficult cancers to treat and for so many years, medical advances in this space have been limited. Today’s approval of Rubraca for the treatment of advanced ovarian cancer demonstrates the value of treatment with PARP inhibitors and represents an important advance for women diagnosed with either germline or somatic BRCA-mutated tumors who have been treated with two or more chemotherapies,” said Robert L. Coleman, MD, Vice Chair, Clinical Research, Ann Rife Cox Chair in Gynecology, Department of Gynecologic Oncology and Reproductive Medicine, M.D. Anderson Cancer Center, Houston, and a principal investigator of the study that led to this approval.
In the 2 trials that led to this approval, 54% of patients responded to Rubraca therapy. The most common side effects with Rubraca were nausea, fatigue, altered taste, diarrhea, anemia, abdominal pain, dyspnea, vomiting, decreased appetite, constipation, and low platelet levels. For more information visit www.rubraca.com.