On April 6, 2018, the FDA approved Rubraca (rucaparib), a poly ADP-ribose polymerase (PARP) inhibitor, developed by Clovis Oncology Inc. for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who are in a complete or partial response to platinum-based chemotherapy. The FDA also concurrently approved the complementary diagnostic test for tumor samples.
Ovarian, fallopian tube, and primary peritoneal cancers are diseases in which malignant cells form in the ovaries, fallopian tubes, or peritoneum. Primary peritoneal cancer is cancer that forms in the tissue that lines the abdominal wall and covers organs in the abdomen and has not spread there from another part of the body. Cancer sometimes begins in the peritoneum and spreads to the ovary. Ovarian epithelial cancer, fallopian tube cancer, and primary peritoneal cancer form in the same type of tissue. In the United States, ovarian cancer is the fifth leading cause of cancer death in women.
Rubraca’s approval was based on a randomized, double-blind, placebo-controlled trial in 561 patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who had been treated with at least two prior treatments of platinum-based chemotherapy and were in complete or partial response to the most recent platinum-based chemotherapy. The trial demonstrated a statistically significant improvement in estimated median progression-free survival (PFS) for patients taking rucaparib compared with patients taking a placebo.
The most common adverse reactions included nausea, fatigue (including asthenia, abnormal physical weakness, or lack of energy), abdominal pain/distension, rash, dysgeusia (distortion of the sense of taste), anemia, ALT/AST elevation (a blood test for liver damage), constipation, vomiting, diarrhea, thrombocytopenia (blood platelet deficiency), nasopharyngitis/upper respiratory infection, stomatitis (inflammation of the mucous membrane of the mouth), decreased appetite, and neutropenia (the presence of abnormally few neutrophils in the blood, leading to increased susceptibility to infection).
See the FDA Drug Approval
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