Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that BRCA2 oncogenic variants status confers therapeutic sensitivity to Abiraterone acetate, Olaparib, Prednisone in patients with Prostate Adenocarcinoma.
The U.S. Food and Drug Administration granted approval to olaparib in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Olaparib's product label states to select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
This statement is based on a regulatory approval from the Food and Drug Administration:
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.