Regulatory approval
Published by the Food and Drug Administration.
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 is written in the approval document as:
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.
Citation
AstraZeneca Pharmaceuticals, LP. Lynparza (olaparib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208558s028lbl.pdf. Revised November 2023. Accessed October 30, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | BRCA1 oncogenic variants | Prostate Adenocarcinoma | Abiraterone acetate, Olaparib, Prednisolone | |
| Sensitivity (+) | BRCA1 pathogenic variants | Prostate Adenocarcinoma | Abiraterone acetate, Olaparib, Prednisolone | |
| Sensitivity (+) | BRCA2 oncogenic variants | Prostate Adenocarcinoma | Abiraterone acetate, Olaparib, Prednisolone | |
| Sensitivity (+) | BRCA2 pathogenic variants | Prostate Adenocarcinoma | Abiraterone acetate, Olaparib, Prednisolone | |
| Sensitivity (+) | BRCA1 oncogenic variants | Prostate Adenocarcinoma | Abiraterone acetate, Olaparib, Prednisone | |
| Sensitivity (+) | BRCA1 pathogenic variants | Prostate Adenocarcinoma | Abiraterone acetate, Olaparib, Prednisone | |
| Sensitivity (+) | BRCA2 oncogenic variants | Prostate Adenocarcinoma | Abiraterone acetate, Olaparib, Prednisone | |
| Sensitivity (+) | BRCA2 pathogenic variants | Prostate Adenocarcinoma | Abiraterone acetate, Olaparib, Prednisone |