Clovis Oncology Inc. has announced a voluntary market withdrawal of Rubraca (rucaparib) in the U.S. as treatment of BRCA-mutated ovarian cancer after 2 or more chemotherapies. This withdrawal became effective on June 10, 2022, and does not affect other indications for Rubraca.
The withdrawal is based on discussions with the U.S. Food and Drug Administration (FDA) following submission of overall survival data from the ARIEL4 trial, which demonstrated an increased risk of death in participants with BRCA-mutated ovarian cancer treated with Rubraca after 2 or more chemotherapies.
Rubraca was initially FDA-approved in 2016 as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer who have been treated with 2 or more chemotherapies. This indication was approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication was contingent upon verification and description of clinical benefit in confirmatory trials.
Rubraca will continue to be available in the U.S. for:
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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.
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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 was 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.
Clovis Oncology Inc. United States Securities And Exchange Commission Form 8-K: Current Report June 16, 2022. Available at: click here. Accessed June 17, 2022.
U.S. Food and Drug Administration (FDA). Full prescribing information for RUBRACA™ (rucaparib) tablets, for oral use. Available at: click here. Accessed June 17, 2022.