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Rubraca Approval History

FDA Approved: Yes (First approved December 19, 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 patients with deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies; and for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Development History and FDA Approval Process for Rubraca

Apr  6, 2018Approval Rubraca (rucaparib) Approved in the U.S. as Maintenance Treatment of Recurrent Ovarian Cancer
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

Further information

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