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Rubraca FDA 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, 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.

Development Timeline for Rubraca

DateArticle
May 15, 2020Approval Rubraca (rucaparib) Approved in the U.S. as Monotherapy Treatment for Patients with BRCA1/2-Mutant, Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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

Further information

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