Rubraca Receives New Indication

May 15, 2020 – The U.S. FDA has approved a new indication for Rubraca® (rucaparib), manufactured by Clovis Oncology. Rubraca is now indicated to treat adult patients who have a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) and have received androgen receptor-directed therapy and a taxane-based chemotherapy.

Approximately 192,000 men are expected to be diagnosed with prostate cancer in the United States in 2020. Those who develop castration-resistant prostate cancer are at high risk of metastatic disease, which is incurable and associated with a poor prognosis. An estimated 43,000 men in the U.S. will be diagnosed with mCRPC in 2020. Roughly 12% of mCRPC patients also possess a deleterious germline and/or somatic mutation in the genes BRCA1 and BRCA2 that may respond to treatment with Rubraca.

In a clinical trial, Rubraca delivered a 44% objective response rate. Although the median duration of response (DOR) could not be evaluated at the time of approval, the range of DOR was 1.7 months to more than 24 months. More than half (56%) of patients with a confirmed objective response to Rubraca had a DOR of at least six months.

Recommended dosing is 600mg taken by mouth twice a day with or without food until disease progression or unacceptable toxicity occur. Patients who are treated with Rubraca for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy. First FDA approved in 2016, Rubraca is also indicated to provide maintenance treatment for certain adults who have epithelial ovarian, fallopian tube, or primary peritoneal cancer. The new mCRPC indication was granted accelerated approval, meaning that continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.