Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRCA1 pathogenic variants status confers therapeutic sensitivity to Rucaparib in patients with Prostate Adenocarcinoma.
The U.S. Food and Drug Administration granted accelerated approval to rucaparib 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. The product label states to select patients for therapy based on an FDA-approved companion diagnostic for rucaparib. Furthermore, it states that this indication is approved under accelerated approval based on objective response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
This statement is based on a regulatory approval from the Food and Drug Administration:
RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated 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. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA. 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.