Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized olaparib as a monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
This is written in the approval document as:
Lynparza is indicated as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
Citation
AstraZeneca AB. Lynparza (olaparib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/lynparza-epar-product-information_en.pdf. Revised August 2024. Accessed August 25, 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 | Olaparib | |
| Sensitivity (+) | BRCA2 oncogenic variants | Prostate Adenocarcinoma | Olaparib | |
| Sensitivity (+) | BRCA1 pathogenic variants | Prostate Adenocarcinoma | Olaparib | |
| Sensitivity (+) | BRCA2 pathogenic variants | Prostate Adenocarcinoma | Olaparib |