​Maintenance Treatment of BRCA-mutated Recurrent Ovarian Cancer

​Select patients for the maintenance treatment of recurrent ovarian cancer with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic) [see Clinical Studies (14.1)].

​An FDA-approved test for the detection of deleterious germline and/or somatic BRCA mutations is not currently available.

Treatment of BRCA-mutated mCRPC after Androgen Receptor-directed Therapy and Chemotherapy

Select patients for the treatment of mCRPC with Rubraca based on the presence of a deleterious BRCA mutation (germline and/or somatic) in plasma specimens [see Clinical Studies (14.2)]. A negative result from a plasma specimen does not mean that the patient's tumor is negative for BRCA mutations. Should the plasma specimen have a negative result, consider performing further genomic testing using tumor specimens as clinically indicated.

Information on the FDA-approved tests for the detection of a BRCA mutation in patients with ovarian cancer or with prostate cancer is available at: http://www.fda.gov/CompanionDiagnostics.