ASTRAZENECA — Lynparza FDA Review (NDA/BLA 206162, 2019)
AstraZeneca PLC · 2019 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details Lynparza (olaparib) capsules' approval as monotherapy for advanced ovarian cancer with germline BRCA mutations. It outlines the approval date, indication, dosage, administration, warnings, and adverse reactions, alongside postmarketing requirements. The report highlights Lynparza's safety profile, noting higher adverse event rates in geriatric patients and those with hepatic/renal impairment. Efficacy data from a single-arm study (Study 1) showed a 34% objective response rate and 7.9-month median duration of response. The document also addresses the non-interchangeability of capsule and tablet formulations and includes an OPDP memorandum confirming no issues with proposed prescribing information updates regarding hypersensitivity and bioavailability data.
Key findings — cited to the page
| Increase in creatinine (Grades 1-4) in patients with 3+ prior lines of chemotherapy | 30 % | Lynparza · p.14 |
| Anemia (Grades 1-4) in gBRCA-mutated ovarian cancer (Lynparza arm) | 25 % | Lynparza · p.15 |
| Anemia (Grades 3-4) in gBRCA-mutated ovarian cancer (Lynparza arm) | 4 % | Lynparza · p.15 |
| Anemia (Grades 1-4) in gBRCA-mutated ovarian cancer (Placebo arm) | 7 % | Lynparza · p.15 |
| Anemia (Grades 3-4) in gBRCA-mutated ovarian cancer (Placebo arm) | 2 % | Lynparza · p.15 |
| Dyspepsia (Grades 1-4) in gBRCA-mutated ovarian cancer (Placebo arm) | 14 % | Lynparza · p.15 |
| Abdominal pain/discomfort (Grades 1-4) in gBRCA-mutated ovarian cancer (Lynparza arm) | 47 % | Lynparza · p.15 |
| Dyspepsia (Grades 3-4) in gBRCA-mutated ovarian cancer (Placebo arm) | 0 % | Lynparza · p.15 |
| Dysgeusia (Grades 1-4) in gBRCA-mutated ovarian cancer (Lynparza arm) | 21 % | Lynparza · p.15 |
| Abdominal pain/discomfort (Grades 3-4) in gBRCA-mutated ovarian cancer (Lynparza arm) | 0 % | Lynparza · p.15 |
| Abdominal pain/discomfort (Grades 1-4) in gBRCA-mutated ovarian cancer (Placebo arm) | 58 % | Lynparza · p.15 |
| Abdominal pain/discomfort (Grades 3-4) in gBRCA-mutated ovarian cancer (Placebo arm) | 2 % | Lynparza · p.15 |
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 →