Rubraca FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 28, 2021.
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, Prostate Cancer
Rubraca (rucaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor for the treatment of ovarian cancer and prostate cancer.
Indications
- Ovarian Cancer
- 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.
- for the treatment of adult patients with a 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. Select patients for therapy based on an FDA-approved companion diagnostic for Rubraca.
- Prostate Cancer
- for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic) associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
- for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic) associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
Development timeline for Rubraca
Further information
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