AstraZeneca PLC — Lynparza FDA Review (NDA/BLA 208558, 2025)
AstraZeneca PLC · 2025 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved AstraZeneca's Lynparza (olaparib) in combination with abiraterone and prednisone/prednisolone for BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) in May 2023. This approval, based on the PROpel study, followed concerns about efficacy and increased toxicity in non-BRCAm populations, leading to a narrower indication. Lynparza's safety profile, detailed across various cancer trials, highlights common adverse reactions, dose modifications, and specific concerns like pneumonitis and venous thromboembolism. Efficacy data from multiple studies (e.g., PAOLA-1, SOLO-2, OlympiA, POLO) consistently demonstrate Lynparza's benefits, particularly in patients with BRCA mutations or HRD-positive tumors, showing improved progression-free and overall survival. Postmarketing commitments include analytical and clinical validation studies for diagnostic devices.
Key findings — cited to the page
| nausea (grades 3-4) in placebo arm | 0 % | SOLO-1 · p.19 |
| fatigue (grades 3-4) in placebo arm | 2 % | SOLO-1 · p.19 |
| nausea (grades 3-4) in placebo arm | 2 % | POLO · p.29 |
| nausea (all grades) in placebo arm | 38 % | SOLO-1 · p.19 |
| fatigue (grades 3-4) in Lynparza arm | 4 % | SOLO-1 · p.19 |
| fatigue (all grades) in placebo arm | 42 % | SOLO-1 · p.19 |
| Incidence of Grade ≥ 3 adverse reactions (olaparib + abiraterone) | 56 % | PROpel · p.87 |
| Incidence of Grade ≥ 3 adverse reactions (abiraterone + placebo) | 43 % | PROpel · p.87 |
| nausea (all grades) in Lynparza arm | 77 % | SOLO-1 · p.19 |
| nausea (grades 3-4) in Lynparza arm | 1 % | SOLO-1 · p.19 |
| fatigue (all grades) in Lynparza arm | 67 % | SOLO-1 · p.19 |
| anemia (all grades) in Lynparza arm | 38 % | SOLO-1 · p.19 |
Source: AstraZeneca PLC ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →