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Rubraca Approval History

Reviewed on Dec 19, 2016 by J.Stewart BPharm
  • FDA approved: Yes (First approved December 19th, 2016)
  • Brand name: Rubraca
  • Generic name: rucaparib
  • Dosage form: Tablets
  • Company: Clovis Oncology, Inc.
  • Treatment for: Ovarian Cancer

Rubraca (rucaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of advanced mutant BRCA ovarian cancer.

Rubraca is indicated as monotherapy for the treatment of women with advanced ovarian cancer who have been treated with two or more chemotherapies, and whose tumors have a specific gene mutation (deleterious BRCA) as identified by the companion diagnostic FoundationFocus CDxBRCA test, which is FDA approved for the selection of patients for Rubraca treatment.

Rubraca was approved under the FDA’s accelerated approval program, based on the objective response rate (ORR) and duration of response (DOR) results from 106 patients in two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2 Parts 1 and 2. The objective response rate was fifty-four percent, with nine percent of patients experiencing complete shrinkage of their tumors, and forty-five percent of patients experiencing partial shrinkage of their tumors, lasting a median of 9.2 months.

Rubraca is administered orally as tablets, taken twice daily with or without food. Common side effects include nausea, fatigue, vomiting, anemia, abdominal pain, unusual taste sensation (dysgeusia), constipation, decreased appetite, diarrhea, low levels of blood platelets (thrombocytopenia) and trouble breathing (dyspnea). Rubraca is associated with serious risks, including myelodysplastic syndrome, acute myeloid leukemia and fetal harm.

Development History and FDA Approval Process for Rubraca

DateArticle
Dec 19, 2016Approval FDA Grants Accelerated Approval to Rubraca (rucaparib) for Advanced Ovarian Cancer
Aug 23, 2016FDA Accepts Clovis Oncology’s NDA for Rucaparib for Priority Review for the Treatment of Advanced Mutant BRCA Ovarian Cancer
Jun  6, 2016Clovis Oncology Presents Data From Phase 2 Studies of Rucaparib in Advanced Ovarian Cancer and Pancreatic Cancer
May 30, 2015Clovis Oncology’S Phase 2 Studies of Rucaparib in Ovarian Cancer Demonstrate Highly Compelling Clinical Activity

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