AstraZeneca PLC — Lynparza FDA Review (NDA208558, ORIG 1, 2017)
AstraZeneca PLC · 2017 · FDA Review (openFDA) · company profile →
Report summary
The FDA's multi-disciplinary review of AstraZeneca's Lynparza (olaparib) tablets recommends approval for maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, and for advanced gBRCAm ovarian cancer after three or more prior chemotherapy lines. Efficacy data from SOLO2 and Study 19 demonstrated significant progression-free survival benefits, particularly in gBRCAm patients. The review addressed the transition from a capsule to a more bioavailable tablet formulation, pharmacokinetic analyses, and drug-drug interactions. Safety concerns include a 1-2% risk of Myelodysplastic Syndromes/Acute Myeloid Leukemia and cases of pneumonitis and other secondary malignancies. The recommended dosage is 300 mg twice daily.
Key findings — cited to the page
| Grade 3-4 AEs | 18 % | SOLO2 (Placebo arm) · p.93 |
| CTCAE Grade 3 or higher anemia (400 mg capsule BID) | 22 % | · p.36 |
| CTCAE Grade 3 or higher anemia (400 mg tablet BID) | 29 % | · p.36 |
| Grade 3-4 AEs | 37 % | SOLO2 (Olaparib arm) · p.93 |
| Grade 1-4 AEs | 95 % | SOLO2 (Placebo arm) · p.93 |
| Grade 1-4 AEs | 99 % | SOLO2 (Olaparib arm) · p.93 |
| CTCAE Grade 3 or higher anemia (300 mg tablet BID) | 22 % | · p.36 |
| Grade 3-4 anemia | 18 % | Olaparib capsule pool (3+ line ovarian cancer) · p.141 |
| Grade 1-4 anemia | 35 % | Olaparib capsule pool (3+ line ovarian cancer) · p.141 |
| Grade 1-4 nausea | 70 % | Olaparib tablet pool (3+ line ovarian cancer) · p.141 |
| Grade 3-4 anemia | 20 % | Olaparib tablet pool (3+ line ovarian cancer) · p.141 |
| Grade 1-4 nausea | 69 % | ISS (tablet formulation) · p.139 |
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 →